Trial Outcomes & Findings for Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection (NCT NCT03637660)
NCT ID: NCT03637660
Last Updated: 2025-01-14
Results Overview
Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
249 participants
Primary outcome timeframe
Day 1 to Day 180
Results posted on
2025-01-14
Participant Flow
Participants were aged 18 years or older with untreated early syphilis recruited from the communities at large around the ten clinical sites. Participants were enrolled between 31OCT2018 and 03MAR2022.
Participant milestones
| Measure |
One Dose BPG 2.4 MU
2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly on Day 1
Benzathine Penicillin: BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock.
|
Three Doses BPG 2.4 MU
2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly weekly for three successive weeks
Benzathine Penicillin: BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
125
|
|
Overall Study
COMPLETED
|
82
|
82
|
|
Overall Study
NOT COMPLETED
|
42
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
Baseline characteristics by cohort
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
34.4 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
35.0 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
242 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
236 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Did Not Complete High School
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Completed High School
|
72 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Completed Junior College
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Completed College (Undergraduate Degree)
|
20 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Completed Graduate Degree
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Stage of Syphilis
Early Latent Syphilis
|
41 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Stage of Syphilis
Primary Syphilis
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Stage of Syphilis
Secondary Syphilis
|
58 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Stage of Syphilis
Missing 'Stage of Syphilis'
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Prior Syphilis History
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Years of Formal Education
|
14.0 years
STANDARD_DEVIATION 2.2 • n=99 Participants
|
14.0 years
STANDARD_DEVIATION 2.0 • n=107 Participants
|
14.0 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 180Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion).
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
The Number of Participants With a Serological Response by Month 6.
|
94 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Gender identity, sexual orientation, sexual partner, sex history in last 60 days
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Man · HIV-infected
|
67 Participants
|
81 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Non-binary · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Non-binary · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Other · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Homosexual / gay / lesbian · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation: Bisexual · HIV-infected
|
9 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Other · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Other · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: Yes · Non HIV-infected
|
47 Participants
|
36 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: Yes · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Oral receptive · Non HIV-infected
|
37 Participants
|
31 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Oral receptive · Unknown HIV status
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Genital/vaginal · HIV-infected
|
6 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Genital/vaginal · Non HIV-infected
|
13 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Genital/vaginal · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: Unknown · HIV-infected
|
0 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for gonorrhea in the past 14 days: Yes · Non HIV-infected
|
15 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for chlamydia in the past 14 days: Yes · HIV-infected
|
30 Participants
|
42 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for chlamydia in the past 14 days: Yes · Non HIV-infected
|
15 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Other · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Other · Non HIV-infected
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Other · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Declined to respond · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Declined to respond · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Woman · HIV-infected
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Woman · Non HIV-infected
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Woman · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Trans male / trans man · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Trans male / trans man · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Trans male / trans man · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Trans female / trans woman · HIV-infected
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Trans female / trans woman · Non HIV-infected
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Trans female / trans woman · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Genderqueer / gender non-conforming · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Genderqueer / gender non-conforming · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Genderqueer / gender non-conforming · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Multiple · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Multiple · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Multiple · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Non-binary · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Other · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Other · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Declined to respond · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Declined to respond · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Declined to respond · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Heterosexual / straight · HIV-infected
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Man · Non HIV-infected
|
46 Participants
|
37 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Gender Identity : Man · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Heterosexual / straight · Non HIV-infected
|
12 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Heterosexual / straight · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Homosexual / gay / lesbian · HIV-infected
|
58 Participants
|
69 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Homosexual / gay / lesbian · Non HIV-infected
|
30 Participants
|
28 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation: Bisexual · Non HIV-infected
|
7 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation: Bisexual · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Orientation : Declined to respond · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Men · HIV-infected
|
59 Participants
|
71 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Men · Non HIV-infected
|
29 Participants
|
27 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Men · Unknown HIV status
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Women · HIV-infected
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Women · Non HIV-infected
|
10 Participants
|
8 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Women · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Trans male/ trans man · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Trans male/ trans man · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Trans male/ trans man · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Trans female/ trans woman · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Trans female/ trans woman · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Trans female/ trans woman · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Multiple · HIV-infected
|
9 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Multiple · Non HIV-infected
|
12 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Multiple · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Other · HIV-infected
|
1 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Declined to respond · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Declined to respond · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual Partner: Declined to respond · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: Yes · HIV-infected
|
57 Participants
|
72 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: No · HIV-infected
|
13 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: No · Non HIV-infected
|
4 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: No · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: Unknown · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: Unknown · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Sexual intercourse in past 60 days: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Oral receptive · HIV-infected
|
43 Participants
|
66 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Oral active · HIV-infected
|
45 Participants
|
58 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Oral active · Non HIV-infected
|
35 Participants
|
28 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Oral active · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Rectal receptive · HIV-infected
|
41 Participants
|
55 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Rectal receptive · Non HIV-infected
|
21 Participants
|
23 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Rectal receptive · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Rectal insertive · HIV-infected
|
38 Participants
|
38 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Rectal insertive · Non HIV-infected
|
22 Participants
|
15 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, Sites of exposure: Rectal insertive · Unknown HIV status
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Always · HIV-infected
|
10 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Always · Non HIV-infected
|
5 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Always · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Sometimes · HIV-infected
|
33 Participants
|
40 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Sometimes · Non HIV-infected
|
28 Participants
|
20 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Sometimes · Unknown HIV status
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Never · HIV-infected
|
14 Participants
|
28 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Never · Non HIV-infected
|
14 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If yes to sexual intercourse in past 60 days, condom or barrier for protection: Never · Unknown HIV status
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: Yes · HIV-infected
|
3 Participants
|
13 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: Yes · Non HIV-infected
|
9 Participants
|
7 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: No · HIV-infected
|
54 Participants
|
53 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: No · Non HIV-infected
|
37 Participants
|
29 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: No · Unknown HIV status
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: Unknown · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Any known exposures to an STD in the past 60 days: Unknown · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with gonorrhea in the past 60 days: Yes · HIV-infected
|
1 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with gonorrhea in the past 60 days: Yes · Non HIV-infected
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with gonorrhea in the past 60 days: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with gonorrhea in the past 60 days: No · HIV-infected
|
69 Participants
|
77 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with gonorrhea in the past 60 days: No · Non HIV-infected
|
49 Participants
|
39 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with gonorrhea in the past 60 days: No · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for gonorrhea in the past 14 days: Yes · HIV-infected
|
30 Participants
|
42 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for gonorrhea in the past 14 days: Yes · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for gonorrhea in the past 14 days: No · HIV-infected
|
40 Participants
|
41 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for gonorrhea in the past 14 days: No · Non HIV-infected
|
36 Participants
|
30 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for gonorrhea in the past 14 days: No · Unknown HIV status
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for gonorrhea in past 14 days, Test results: Positive · HIV-infected
|
1 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for gonorrhea in past 14 days, Test results: Positive · Non HIV-infected
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for gonorrhea in past 14 days, Test results: Positive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for gonorrhea in past 14 days, Test results: Negative · HIV-infected
|
29 Participants
|
39 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for gonorrhea in past 14 days, Test results: Negative · Non HIV-infected
|
13 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for gonorrhea in past 14 days, Test results: Negative · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with chlamydia in the past 60 days: Yes · HIV-infected
|
7 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with chlamydia in the past 60 days: Yes · Non HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with chlamydia in the past 60 days: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with chlamydia in the past 60 days: No · HIV-infected
|
63 Participants
|
77 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with chlamydia in the past 60 days: No · Non HIV-infected
|
51 Participants
|
39 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with chlamydia in the past 60 days: No · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for chlamydia in the past 14 days: Yes · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for chlamydia in the past 14 days: No · HIV-infected
|
40 Participants
|
41 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for chlamydia in the past 14 days: No · Non HIV-infected
|
36 Participants
|
30 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Tested for chlamydia in the past 14 days: No · Unknown HIV status
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for chlamydia in the past 14 days, Test results: Positive · HIV-infected
|
7 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for chlamydia in the past 14 days, Test results: Positive · Non HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for chlamydia in the past 14 days, Test results: Positive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for chlamydia in the past 14 days, Test results: Negative · HIV-infected
|
23 Participants
|
37 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for chlamydia in the past 14 days, Test results: Negative · Non HIV-infected
|
15 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
If tested for chlamydia in the past 14 days, Test results: Negative · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with any other STI in the past 60 days: Yes · HIV-infected
|
4 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with any other STI in the past 60 days: Yes · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with any other STI in the past 60 days: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with any other STI in the past 60 days: No · HIV-infected
|
66 Participants
|
83 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with any other STI in the past 60 days: No · Non HIV-infected
|
51 Participants
|
40 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Diagnosed with any other STI in the past 60 days: No · Unknown HIV status
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. Participants contributing to this outcome measure include those who answered yes to either having intercourse in the past 60 days or reported being diagnosed with at least one STI in the past 60 days.
Sex history in last 60 days
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=105 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=111 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Days since last had sexual intercourse in the past 60 days (HIV-infected)
|
14.3 days
Standard Deviation 13.0
|
13.0 days
Standard Deviation 12.1
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Days since last had sexual intercourse in the past 60 days (HIV-uninfected)
|
16.8 days
Standard Deviation 12.7
|
12.6 days
Standard Deviation 10.2
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Days since last diagnosed with gonorrhea in the past 60 days (HIV-infected)
|
1.0 days
Standard Deviation NA
only one participant reported as diagnosed with gonorrhea, SD could not be calculated
|
24.7 days
Standard Deviation 26.4
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Days since last diagnosed with gonorrhea in the past 60 days (HIV-uninfected)
|
7.5 days
Standard Deviation 0.7
|
13.0 days
Standard Deviation NA
only one participant reported as diagnosed with gonorrhea, SD could not be calculated
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Days since last diagnosed with chlamydia in the past 60 days (HIV-infected)
|
3.4 days
Standard Deviation 3.6
|
12.7 days
Standard Deviation 21.6
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Days since last diagnosed with chlamydia in the past 60 days (HIV-uninfected)
|
—
|
13.0 days
Standard Deviation NA
only one participant reported as diagnosed with chlamydia, SD could not be calculated
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Days since last diagnosed with any other STI in the past 60 days (HIV-infected)
|
3.3 days
Standard Deviation 2.5
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included. Participants contributing to this outcome measure include those who answered yes to either having intercourse in the past 60 days or reported being diagnosed with at least one STI in the past 60 days.
Sex history in last 60 days
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=105 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=111 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Total number of partners in the past 60 days (HIV-infected)
|
4.6 count of partners
Standard Deviation 13.2
|
3.5 count of partners
Standard Deviation 4.3
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Total number of partners in the past 60 days (HIV-uninfected)
|
3.9 count of partners
Standard Deviation 4.8
|
6.1 count of partners
Standard Deviation 9.7
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of new partners (HIV-infected)
|
2.0 count of partners
Standard Deviation 6.9
|
1.7 count of partners
Standard Deviation 2.9
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of new partners (HIV-uninfected)
|
2.1 count of partners
Standard Deviation 3.4
|
2.8 count of partners
Standard Deviation 5.2
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of regular partners (HIV-infected)
|
2.0 count of partners
Standard Deviation 6.6
|
1.4 count of partners
Standard Deviation 1.6
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of regular partners (HIV-uninfected)
|
1.5 count of partners
Standard Deviation 2.7
|
1.5 count of partners
Standard Deviation 2.7
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of occasional partners (HIV-infected)
|
0.7 count of partners
Standard Deviation 1.3
|
0.6 count of partners
Standard Deviation 1.5
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of occasional partners (HIV-uninfected)
|
0.8 count of partners
Standard Deviation 1.6
|
1.9 count of partners
Standard Deviation 3.9
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of male partners (HIV-infected)
|
4.4 count of partners
Standard Deviation 13.0
|
3.4 count of partners
Standard Deviation 4.3
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of male partners (HIV-uninfected)
|
3.3 count of partners
Standard Deviation 4.9
|
5.7 count of partners
Standard Deviation 9.9
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of female partners (HIV-infected)
|
0.1 count of partners
Standard Deviation 0.5
|
0.1 count of partners
Standard Deviation 0.3
|
|
Continuous Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Number of female partners (HIV-uninfected)
|
0.6 count of partners
Standard Deviation 1.4
|
0.4 count of partners
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Day 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Highest level of education completed, stage of syphilis, prior syphilis history
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Did not complete high school · HIV-infected
|
3 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Did not complete high school · HIV-uninfected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Did not complete high school · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed high school · HIV-infected
|
40 Participants
|
52 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed high school · HIV-uninfected
|
31 Participants
|
23 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed high school · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed junior college · HIV-infected
|
6 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed junior college · HIV-uninfected
|
9 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed junior college · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed Completed college (undergraduate degree) · HIV-infected
|
14 Participants
|
24 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed Completed college (undergraduate degree) · HIV-uninfected
|
5 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Highest level of education completed: Completed Completed college (undergraduate degree) · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Completed graduate degree · HIV-infected
|
7 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Completed graduate degree · HIV-uninfected
|
5 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Completed graduate degree · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Early latent syphilis · HIV-infected
|
25 Participants
|
31 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Early latent syphilis · HIV-uninfected
|
14 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Early latent syphilis · Unknown HIV status
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Primary syphilis · HIV-infected
|
10 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Primary syphilis · HIV-uninfected
|
14 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Primary syphilis · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Secondary syphilis · HIV-infected
|
35 Participants
|
39 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Secondary syphilis · HIV-uninfected
|
23 Participants
|
20 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Stage of syphilis: Secondary syphilis · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Prior syphilis history: Yes · HIV-infected
|
5 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Prior syphilis history: Yes · HIV-uninfected
|
4 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
Prior syphilis history: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Years of formal education
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire
HIV-infected
|
37.5 years
Standard Deviation 11.9
|
36.5 years
Standard Deviation 9.7
|
|
Continuous Descriptive Statistics of Socio-epidemiologic Characterictics at Baseline Collected Via a Study-specific Questionnaire
HIV-uninfected
|
33.4 years
Standard Deviation 11.5
|
30.1 years
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Day 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Sex, Ethnicity, Race
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Asian · HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Asian · HIV-uninfected
|
0 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Asian · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Sex: Male · HIV-infected
|
68 Participants
|
83 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Sex: Male · HIV-uninfected
|
48 Participants
|
38 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Sex: Male · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Sex: Female · HIV-infected
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Sex: Female · HIV-uninfected
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Sex: Female · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Not Hispanic or Latino · HIV-infected
|
64 Participants
|
80 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Not Hispanic or Latino · HIV-uninfected
|
49 Participants
|
38 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Not Hispanic or Latino · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Hispanic or Latino · HIV-infected
|
6 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Hispanic or Latino · HIV-uninfected
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Hispanic or Latino · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Not Reported · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Not Reported · HIV-uninfected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Ethnicity: Not Reported · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: American Indian or Alaskan Native · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: American Indian or Alaskan Native · HIV-uninfected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: American Indian or Alaskan Native · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Native Hawaiian or Other Pacific Islander · HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Native Hawaiian or Other Pacific Islander · HIV-uninfected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Native Hawaiian or Other Pacific Islander · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Black or African American · HIV-infected
|
40 Participants
|
57 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Black or African American · HIV-uninfected
|
32 Participants
|
22 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Black or African American · Unknown HIV status
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: White · HIV-infected
|
20 Participants
|
14 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: White · HIV-uninfected
|
15 Participants
|
14 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: White · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Multi-Racial · HIV-infected
|
7 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Multi-Racial · HIV-uninfected
|
4 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Multi-Racial · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Unknown · HIV-infected
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Unknown · HIV-uninfected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Race: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Age
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
HIV-uninfected
|
33.4 years
Standard Deviation 11.5
|
30.1 years
Standard Deviation 10.2
|
|
Continuous Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
HIV-infected
|
37.5 years
Standard Deviation 11.9
|
36.5 years
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Through Month 12Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Compliance with study product will be defined as the participant received all assigned doses within the assigned visit windows. A participant is not adherent to study product if they miss at least one dose or receive at least one dose out of the visit window.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
The Number of Participants Who Receive All Assigned Doses Within the Assigned Visit Windows
|
124 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 2Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Approximately 24 hours after Visit 1, participants were contacted and evaluated for symptoms of a JHR, which included fever, chills, myalgia, weakness, flushing, worsening of skin rash, tachycardia, heart palpitations, arthralgia, nausea, headache, and dizziness, including time of onset and time of resolution of each symptom reported.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
The Number of Participants Who Report Jarisch-Herxheimer Reaction Manifestations
|
27 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 180Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Serological response to therapy by Month 6 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 6 visit window (i.e., scheduled visits up to and including the Month 6 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 6 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 6 visit window (i.e., seroreversion). Serological response to therapy by Month 6 was examined among participants with and without HIV infection,
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Number of Participants With Serological Response by Month 6 Among Participants With or Without HIV Infection
HIV-infected
|
53 Participants
|
59 Participants
|
|
Number of Participants With Serological Response by Month 6 Among Participants With or Without HIV Infection
HIV-uninfected
|
39 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Through month 12Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 12 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 12 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 12 visit window (i.e., seroreversion).
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Number of Participants With Serological Response (Defined as Either a 4-fold or Greater Decline in Rapid Plasma Regain (RPR) Titer Compared to Baseline or Being Rapid Plasma Regain -Negative [Seroreversion]) by Month 12.
|
97 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Through month 12Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Serological response to therapy by Month 12 was defined as follows, where available rapid plasma reagin (RPR) results from all visits prior to the end of the Month 12 visit window (i.e., scheduled visits up to and including the Month 12 visit, early termination visit, or any unscheduled visit that occurred prior to the end of month 6 visit window) were evaluated: * 4-fold or greater decline in RPR titer at any visit prior to the end of the Month 12 visit window compared to baseline, OR * RPR-negative at any visit prior to the end of the Month 12visit window (i.e., seroreversion). Serological response to therapy by Month 12 was examined among participants with and without HIV infection,
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Number of Participants With Serological Response by Month 12 Among Subjects With or Without HIV Infection
HIV-infected
|
55 Participants
|
60 Participants
|
|
Number of Participants With Serological Response by Month 12 Among Subjects With or Without HIV Infection
HIV-uninfected
|
40 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Through week 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Sex history since last visit.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · HIV-infected
|
1 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Non HIV-infected
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · HIV-infected
|
6 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Non HIV-infected
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · HIV-infected
|
61 Participants
|
67 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Non HIV-infected
|
43 Participants
|
35 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Unknown HIV status
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · HIV-infected
|
4 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Non HIV-infected
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · HIV-infected
|
4 Participants
|
7 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Non HIV-infected
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · HIV-infected
|
3 Participants
|
7 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Non HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · HIV-infected
|
1 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Non HIV-infected
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · HIV-infected
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Non HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · HIV-infected
|
3 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Non HIV-infected
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · HIV-infected
|
5 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Non HIV-infected
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · HIV-infected
|
6 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Non HIV-infected
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Non HIV-infected
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · HIV-infected
|
58 Participants
|
67 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Non HIV-infected
|
42 Participants
|
36 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Unknown HIV status
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · HIV-infected
|
9 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Non HIV-infected
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Unknown HIV status
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through week 2Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Sex history since last visit.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · HIV-infected
|
15 Participants
|
15 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Non HIV-infected
|
15 Participants
|
13 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · HIV-infected
|
46 Participants
|
58 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Non HIV-infected
|
31 Participants
|
23 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Unknown HIV status
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · HIV-infected
|
12 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Non HIV-infected
|
9 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · HIV-infected
|
7 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Non HIV-infected
|
10 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · HIV-infected
|
7 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Non HIV-infected
|
10 Participants
|
8 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · HIV-infected
|
7 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Non HIV-infected
|
6 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
3If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · HIV-infected
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
3If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Non HIV-infected
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
3If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · HIV-infected
|
6 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Non HIV-infected
|
8 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · HIV-infected
|
4 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Non HIV-infected
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · HIV-infected
|
5 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Non HIV-infected
|
5 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · HIV-infected
|
14 Participants
|
14 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Non HIV-infected
|
12 Participants
|
13 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · HIV-infected
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Non HIV-infected
|
3 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · HIV-infected
|
14 Participants
|
14 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Non HIV-infected
|
13 Participants
|
13 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · HIV-infected
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Non HIV-infected
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · HIV-infected
|
52 Participants
|
63 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Non HIV-infected
|
43 Participants
|
35 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Unknown HIV status
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · HIV-infected
|
9 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Non HIV-infected
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Unknown HIV status
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through month 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Sex history since last visit.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Known re-exposure · HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Known re-exposure · Non HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Known re-exposure · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · Non HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · HIV-infected
|
21 Participants
|
30 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Non HIV-infected
|
21 Participants
|
17 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · HIV-infected
|
36 Participants
|
39 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Non HIV-infected
|
25 Participants
|
18 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Unknown HIV status
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · HIV-infected
|
12 Participants
|
26 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Non HIV-infected
|
15 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · HIV-infected
|
11 Participants
|
24 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Non HIV-infected
|
13 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · HIV-infected
|
10 Participants
|
18 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Non HIV-infected
|
5 Participants
|
8 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · HIV-infected
|
9 Participants
|
15 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Non HIV-infected
|
7 Participants
|
7 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Non HIV-infected
|
6 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · HIV-infected
|
11 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Non HIV-infected
|
10 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · HIV-infected
|
3 Participants
|
7 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Non HIV-infected
|
7 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · HIV-infected
|
7 Participants
|
17 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Non HIV-infected
|
5 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Non HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · HIV-infected
|
21 Participants
|
28 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Non HIV-infected
|
21 Participants
|
16 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · HIV-infected
|
—
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Non HIV-infected
|
—
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Unknown HIV status
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · HIV-infected
|
21 Participants
|
28 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Non HIV-infected
|
21 Participants
|
16 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · HIV-infected
|
—
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Non HIV-infected
|
—
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Unknown HIV status
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Non HIV-infected
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · HIV-infected
|
47 Participants
|
59 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Non HIV-infected
|
43 Participants
|
32 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Unknown HIV status
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · HIV-infected
|
10 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Non HIV-infected
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Unknown HIV status
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through month 3Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Sex history since last visit.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · HIV-infected
|
40 Participants
|
47 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Non HIV-infected
|
29 Participants
|
27 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Unknown HIV status
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · HIV-infected
|
18 Participants
|
17 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Non HIV-infected
|
10 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · HIV-infected
|
32 Participants
|
40 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Non HIV-infected
|
26 Participants
|
23 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Unknown HIV status
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · HIV-infected
|
30 Participants
|
40 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Non HIV-infected
|
23 Participants
|
21 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Unknown HIV status
|
0 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · HIV-infected
|
28 Participants
|
34 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Non HIV-infected
|
14 Participants
|
15 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · HIV-infected
|
26 Participants
|
28 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Non HIV-infected
|
18 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Unknown HIV status
|
0 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · HIV-infected
|
2 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Non HIV-infected
|
9 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · HIV-infected
|
13 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Non HIV-infected
|
12 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · HIV-infected
|
15 Participants
|
18 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Non HIV-infected
|
14 Participants
|
7 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · HIV-infected
|
12 Participants
|
20 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Non HIV-infected
|
4 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Non HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · HIV-infected
|
36 Participants
|
46 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Non HIV-infected
|
27 Participants
|
27 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Unknown HIV status
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · HIV-infected
|
4 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · Non HIV-infected
|
2 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · HIV-infected
|
37 Participants
|
45 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Non HIV-infected
|
26 Participants
|
25 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Unknown HIV status
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · HIV-infected
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · HIV-infected
|
52 Participants
|
55 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Non HIV-infected
|
36 Participants
|
28 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Unknown HIV status
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · HIV-infected
|
5 Participants
|
7 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Non HIV-infected
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Non HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · HIV-infected
|
—
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · Non HIV-infected
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · Unknown HIV status
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Through month 6Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Sex history since last visit.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Non HIV-infected
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · Non HIV-infected
|
5 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · HIV-infected
|
2 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · HIV-infected
|
44 Participants
|
45 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Non HIV-infected
|
28 Participants
|
21 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · HIV-infected
|
7 Participants
|
16 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Non HIV-infected
|
4 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · HIV-infected
|
—
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · Non HIV-infected
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · Unknown HIV status
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · HIV-infected
|
37 Participants
|
37 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Non HIV-infected
|
21 Participants
|
16 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · HIV-infected
|
32 Participants
|
40 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Non HIV-infected
|
21 Participants
|
17 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · HIV-infected
|
29 Participants
|
33 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Non HIV-infected
|
15 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · HIV-infected
|
25 Participants
|
33 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Non HIV-infected
|
17 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · HIV-infected
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Non HIV-infected
|
8 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · HIV-infected
|
12 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Non HIV-infected
|
6 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · HIV-infected
|
15 Participants
|
16 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Non HIV-infected
|
16 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · HIV-infected
|
17 Participants
|
20 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Non HIV-infected
|
6 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · HIV-infected
|
43 Participants
|
44 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Non HIV-infected
|
26 Participants
|
21 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · HIV-infected
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · HIV-infected
|
41 Participants
|
41 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Non HIV-infected
|
22 Participants
|
19 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · HIV-infected
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Non HIV-infected
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · HIV-infected
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Non HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · HIV-infected
|
48 Participants
|
58 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Non HIV-infected
|
31 Participants
|
23 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · HIV-infected
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · HIV-infected
|
—
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Non HIV-infected
|
—
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Unknown HIV status
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Return worsening sx · HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Return worsening sx · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Return worsening sx · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Other · Unknown HIV status
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Through month 9Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Sex history since last visit.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · HIV-infected
|
38 Participants
|
45 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Non HIV-infected
|
28 Participants
|
15 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · HIV-infected
|
13 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Non HIV-infected
|
3 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · HIV-infected
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · Non HIV-infected
|
—
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · Unknown HIV status
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · HIV-infected
|
30 Participants
|
38 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Non HIV-infected
|
18 Participants
|
13 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · HIV-infected
|
32 Participants
|
40 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Non HIV-infected
|
23 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · HIV-infected
|
25 Participants
|
33 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Non HIV-infected
|
13 Participants
|
9 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · HIV-infected
|
23 Participants
|
29 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Non HIV-infected
|
17 Participants
|
5 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · HIV-infected
|
2 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Non HIV-infected
|
8 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · HIV-infected
|
7 Participants
|
13 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Non HIV-infected
|
9 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · HIV-infected
|
17 Participants
|
17 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Non HIV-infected
|
11 Participants
|
7 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · HIV-infected
|
14 Participants
|
16 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Non HIV-infected
|
9 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · HIV-infected
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · HIV-infected
|
37 Participants
|
43 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Non HIV-infected
|
27 Participants
|
15 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · HIV-infected
|
—
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Non HIV-infected
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Unknown HIV status
|
—
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · HIV-infected
|
1 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · Non HIV-infected
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · HIV-infected
|
37 Participants
|
42 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Non HIV-infected
|
25 Participants
|
13 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · HIV-infected
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Non HIV-infected
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · HIV-infected
|
3 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Non HIV-infected
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · HIV-infected
|
49 Participants
|
54 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Non HIV-infected
|
29 Participants
|
19 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Unknown HIV status
|
2 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · HIV-infected
|
3 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Non HIV-infected
|
3 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Known re-exposure · HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Known re-exposure · Non HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Known re-exposure · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Return worsening sx · HIV-infected
|
0 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Return worsening sx · Non HIV-infected
|
3 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Return worsening sx · Unknown HIV status
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through month 12Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
Sex history since last visit.
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=124 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · HIV-infected
|
36 Participants
|
38 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Non HIV-infected
|
23 Participants
|
14 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Yes · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · HIV-infected
|
11 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Non HIV-infected
|
3 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: No · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Sexual intercourse since last visit: Unknown · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · HIV-infected
|
27 Participants
|
32 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Non HIV-infected
|
15 Participants
|
8 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral receptive · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · HIV-infected
|
30 Participants
|
31 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Non HIV-infected
|
17 Participants
|
11 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Oral active · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · HIV-infected
|
20 Participants
|
27 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Non HIV-infected
|
10 Participants
|
10 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal receptive · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · HIV-infected
|
22 Participants
|
23 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Non HIV-infected
|
11 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Rectal insertive · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · HIV-infected
|
5 Participants
|
3 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Non HIV-infected
|
9 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, sites of exposure: Genital/vaginal · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · HIV-infected
|
7 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Non HIV-infected
|
4 Participants
|
6 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Always · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · HIV-infected
|
23 Participants
|
16 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Non HIV-infected
|
10 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Sometimes · Unknown HIV status
|
0 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · HIV-infected
|
6 Participants
|
16 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Non HIV-infected
|
9 Participants
|
4 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
If yes to sexual intercourse since last visit, condom or barrier for protection: Never · Unknown HIV status
|
1 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Yes · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · HIV-infected
|
33 Participants
|
38 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Non HIV-infected
|
23 Participants
|
14 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: No · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · HIV-infected
|
2 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to syphilis since last visit: Unknown · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · HIV-infected
|
3 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · Non HIV-infected
|
2 Participants
|
2 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Yes · Unknown HIV status
|
0 Participants
|
0 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · HIV-infected
|
32 Participants
|
37 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Non HIV-infected
|
21 Participants
|
12 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: No · Unknown HIV status
|
1 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Non HIV-infected
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Any known exposures to another STD since last visit: Unknown · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · HIV-infected
|
3 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Non HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: Yes · Unknown HIV status
|
0 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · HIV-infected
|
45 Participants
|
49 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Non HIV-infected
|
25 Participants
|
17 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, treated or require retreatment for syphilis apart from study treatment: No · Unknown HIV status
|
2 Participants
|
1 Participants
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · HIV-infected
|
3 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Non HIV-infected
|
1 Participants
|
—
|
|
Categorical Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Since last visit, if treated for syphilis how was retreatment need determined: Local RPR results · Unknown HIV status
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Through week 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Sex history since last visit
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (HIV-infected)
|
1 count of partners
Standard Deviation 0
|
1.5 count of partners
Standard Deviation 1.5
|
|
Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (non HIV-infected)
|
1.7 count of partners
Standard Deviation 1.2
|
1.0 count of partners
Standard Deviation 0
|
|
Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (HIV-infected)
|
0.3 count of partners
Standard Deviation 0.5
|
0.3 count of partners
Standard Deviation 0.5
|
|
Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (non HIV-infected)
|
0.7 count of partners
Standard Deviation 1.2
|
0.5 count of partners
Standard Deviation 0.7
|
|
Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (HIV-infected)
|
0.7 count of partners
Standard Deviation 0.5
|
1.3 count of partners
Standard Deviation 1.6
|
|
Continuous Descriptive Statistics of Sexual History at Week 1 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (Non HIV-infected)
|
1.0 count of partners
Standard Deviation 0
|
0.5 count of partners
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Through week 2Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Sex history since last visit
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (HIV-infected)
|
1.0 count of partners
Standard Deviation 0
|
1.9 count of partners
Standard Deviation 2.3
|
|
Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (non HIV-infected)
|
1.3 count of partners
Standard Deviation 0.8
|
1.0 count of partners
Standard Deviation 0
|
|
Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (HIV-infected)
|
0.2 count of partners
Standard Deviation 0.4
|
0.6 count of partners
Standard Deviation 0.9
|
|
Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (non HIV-infected)
|
0.5 count of partners
Standard Deviation 0.5
|
0.2 count of partners
Standard Deviation 0.4
|
|
Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (HIV-infected)
|
0.8 count of partners
Standard Deviation 0.4
|
1.3 count of partners
Standard Deviation 2.0
|
|
Continuous Descriptive Statistics of Sexual History at Week 2 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (Non HIV-infected)
|
0.8 count of partners
Standard Deviation 0.8
|
0.8 count of partners
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Through month 1Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Sex history since last visit
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (HIV-infected)
|
1.2 count of partners
Standard Deviation 0.5
|
1.5 count of partners
Standard Deviation 0.7
|
|
Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (non HIV-infected)
|
1.5 count of partners
Standard Deviation 1.2
|
1.8 count of partners
Standard Deviation 1.6
|
|
Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (HIV-infected)
|
0.3 count of partners
Standard Deviation 0.7
|
0.4 count of partners
Standard Deviation 0.8
|
|
Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (non HIV-infected)
|
0.4 count of partners
Standard Deviation 0.8
|
0.8 count of partners
Standard Deviation 1.4
|
|
Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (HIV-infected)
|
0.9 count of partners
Standard Deviation 0.6
|
1.1 count of partners
Standard Deviation 0.6
|
|
Continuous Descriptive Statistics of Sexual History at Month 1 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (Non HIV-infected)
|
1.1 count of partners
Standard Deviation 0.7
|
1.0 count of partners
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Through month 3Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Sex history since last visit
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (HIV-infected)
|
2.1 count of partners
Standard Deviation 1.9
|
1.9 count of partners
Standard Deviation 1.1
|
|
Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (non HIV-infected)
|
3.1 count of partners
Standard Deviation 3.8
|
4.4 count of partners
Standard Deviation 9.2
|
|
Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (HIV-infected)
|
1.2 count of partners
Standard Deviation 2.2
|
0.5 count of partners
Standard Deviation 0.8
|
|
Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (non HIV-infected)
|
1.3 count of partners
Standard Deviation 2.2
|
2.6 count of partners
Standard Deviation 7.6
|
|
Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (HIV-infected)
|
0.9 count of partners
Standard Deviation 0.7
|
1.4 count of partners
Standard Deviation 1.0
|
|
Continuous Descriptive Statistics of Sexual History at Month 3 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (Non HIV-infected)
|
1.8 count of partners
Standard Deviation 1.9
|
1.8 count of partners
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Through month 6Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Sex history since last visit
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (HIV-infected)
|
2.7 count of partners
Standard Deviation 4.6
|
2.2 count of partners
Standard Deviation 1.8
|
|
Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (non HIV-infected)
|
5.2 count of partners
Standard Deviation 10.7
|
2.7 count of partners
Standard Deviation 2.1
|
|
Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (HIV-infected)
|
1.3 count of partners
Standard Deviation 3.9
|
0.7 count of partners
Standard Deviation 1.2
|
|
Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (non HIV-infected)
|
2.0 count of partners
Standard Deviation 5.5
|
1.0 count of partners
Standard Deviation 1.3
|
|
Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (HIV-infected)
|
1.4 count of partners
Standard Deviation 1.4
|
1.5 count of partners
Standard Deviation 1.3
|
|
Continuous Descriptive Statistics of Sexual History at Month 6 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (Non HIV-infected)
|
3.2 count of partners
Standard Deviation 7.5
|
1.7 count of partners
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Through month 9Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Sex history since last visit
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (HIV-infected)
|
2.0 count of partners
Standard Deviation 1.2
|
2.1 count of partners
Standard Deviation 1.8
|
|
Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (non HIV-infected)
|
6.3 count of partners
Standard Deviation 14.0
|
2.8 count of partners
Standard Deviation 3.0
|
|
Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (HIV-infected)
|
0.6 count of partners
Standard Deviation 1.0
|
0.7 count of partners
Standard Deviation 1.7
|
|
Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (non HIV-infected)
|
3.3 count of partners
Standard Deviation 9.8
|
1.2 count of partners
Standard Deviation 2.1
|
|
Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (HIV-infected)
|
1.4 count of partners
Standard Deviation 0.8
|
1.4 count of partners
Standard Deviation 1.0
|
|
Continuous Descriptive Statistics of Sexual History at Month 9 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (Non HIV-infected)
|
3.0 count of partners
Standard Deviation 6.1
|
1.6 count of partners
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Through month 12Population: The ITT Population includes all randomized subjects, regardless of whether they received study treatment or were compliant with the administration procedures or schedule. Participants with unknown HIV status not included.
Sex history since last visit
Outcome measures
| Measure |
One Dose BPG 2.4 MU
n=121 Participants
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=123 Participants
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (Non HIV-infected)
|
3.8 count of partners
Standard Deviation 6.0
|
1.4 count of partners
Standard Deviation 1.3
|
|
Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (HIV-infected)
|
2.1 count of partners
Standard Deviation 1.3
|
3.3 count of partners
Standard Deviation 8.1
|
|
Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Total number of partners since last visit (non HIV-infected)
|
8.1 count of partners
Standard Deviation 15.9
|
1.9 count of partners
Standard Deviation 1.2
|
|
Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (HIV-infected)
|
0.8 count of partners
Standard Deviation 1.3
|
1.6 count of partners
Standard Deviation 5.5
|
|
Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Number of new partners since last visit (non HIV-infected)
|
4.3 count of partners
Standard Deviation 10.9
|
0.6 count of partners
Standard Deviation 0.8
|
|
Continuous Descriptive Statistics of Sexual History at Month 12 Collected Via a Study-specific Questionnaire
Number of continuing partners since last visit (HIV-infected)
|
1.3 count of partners
Standard Deviation 1.0
|
1.8 count of partners
Standard Deviation 2.8
|
Adverse Events
One Dose BPG 2.4 MU
Serious events: 1 serious events
Other events: 98 other events
Deaths: 0 deaths
Three Doses BPG 2.4 MU
Serious events: 2 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
One Dose BPG 2.4 MU
n=124 participants at risk
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 participants at risk
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Gastrointestinal disorders
Proctocolitis
|
0.81%
1/124 • Number of events 1 • Day 1 through Day 31
|
0.00%
0/125 • Day 1 through Day 31
|
|
Psychiatric disorders
Substance Induced Psychotic Disorder
|
0.00%
0/124 • Day 1 through Day 31
|
0.80%
1/125 • Number of events 1 • Day 1 through Day 31
|
|
Nervous system disorders
Right Sided Facial Weakness
|
0.00%
0/124 • Day 1 through Day 31
|
0.80%
1/125 • Number of events 1 • Day 1 through Day 31
|
Other adverse events
| Measure |
One Dose BPG 2.4 MU
n=124 participants at risk
2.4 MU of BPG intramuscularly on Day 1
|
Three Doses BPG 2.4 MU
n=125 participants at risk
2.4 MU of BPG intramuscularly weekly for three successive weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/124 • Day 1 through Day 31
|
6.4%
8/125 • Number of events 8 • Day 1 through Day 31
|
|
General disorders
Asthenia
|
7.3%
9/124 • Number of events 9 • Day 1 through Day 31
|
11.2%
14/125 • Number of events 14 • Day 1 through Day 31
|
|
General disorders
Chills
|
8.9%
11/124 • Number of events 11 • Day 1 through Day 31
|
12.8%
16/125 • Number of events 16 • Day 1 through Day 31
|
|
General disorders
Injection Site Induration
|
5.6%
7/124 • Number of events 7 • Day 1 through Day 31
|
13.6%
17/125 • Number of events 17 • Day 1 through Day 31
|
|
General disorders
Injection Site Pain
|
75.8%
94/124 • Number of events 94 • Day 1 through Day 31
|
84.8%
106/125 • Number of events 106 • Day 1 through Day 31
|
|
General disorders
Pyrexia
|
7.3%
9/124 • Number of events 9 • Day 1 through Day 31
|
9.6%
12/125 • Number of events 12 • Day 1 through Day 31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
12/124 • Number of events 12 • Day 1 through Day 31
|
14.4%
18/125 • Number of events 18 • Day 1 through Day 31
|
|
Nervous system disorders
Headache
|
6.5%
8/124 • Number of events 8 • Day 1 through Day 31
|
7.2%
9/125 • Number of events 9 • Day 1 through Day 31
|
Additional Information
Edward W. Hook, III
University of Alabama at Birmingham
Phone: 205-932-4204
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60