Trial Outcomes & Findings for Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy (NCT NCT00099632)
NCT ID: NCT00099632
Last Updated: 2021-11-04
Results Overview
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint. 10 participants who did not have resistance samples available were excluded from the primary endpoint analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
484 participants
Primary outcome timeframe
2 and 6 weeks after completion of treatment
Results posted on
2021-11-04
Participant Flow
Study participants were recruited at 8 sites: 2 from South Africa, 2 from India, and 1 each from Haiti, Uganda, Tanzania, and Malawi, between January 2007 to October 2009.
62 participants who randomized but did not start study treatment were excluded from the analysis. These 62 participants were either off study prior to delivery or delivered on study but did not take any dose of study treatment. All the analyses were restricted to the 422 women who received study treatment.
Participant milestones
| Measure |
7-day Lamivudine/Zidovudine (3TC/ZDV)
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
|
21-day Lamivudine/Zidovudine (3TC/ZDV)
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
|
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
|
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
|
7-day Lopinavir/Ritonavir (LPV/r)
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
|
21-day Lopinavir/Ritonavir (LPV/r)
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
68
|
75
|
67
|
71
|
68
|
|
Overall Study
COMPLETED
|
72
|
67
|
72
|
66
|
70
|
66
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
7-day Lamivudine/Zidovudine (3TC/ZDV)
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
|
21-day Lamivudine/Zidovudine (3TC/ZDV)
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
|
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
|
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
|
7-day Lopinavir/Ritonavir (LPV/r)
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
|
21-day Lopinavir/Ritonavir (LPV/r)
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
3
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
Baseline characteristics by cohort
| Measure |
7-day Lamivudine/Zidovudine (3TC/ZDV)
n=73 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
|
21-day Lamivudine/Zidovudine (3TC/ZDV)
n=68 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
|
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=75 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
|
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=67 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
|
7-day Lopinavir/Ritonavir (LPV/r)
n=71 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
|
21-day Lopinavir/Ritonavir (LPV/r)
n=68 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
Total
n=422 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 6 • n=99 Participants
|
27 years
STANDARD_DEVIATION 5 • n=107 Participants
|
26 years
STANDARD_DEVIATION 5 • n=206 Participants
|
26 years
STANDARD_DEVIATION 5 • n=7 Participants
|
27 years
STANDARD_DEVIATION 6 • n=31 Participants
|
26 years
STANDARD_DEVIATION 5 • n=30 Participants
|
27 years
STANDARD_DEVIATION 5 • n=3 Participants
|
|
Age, Customized
Between 13 and 19 years
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
3 participants
n=30 Participants
|
17 participants
n=3 Participants
|
|
Age, Customized
Between 20 and 29 years
|
49 participants
n=99 Participants
|
46 participants
n=107 Participants
|
53 participants
n=206 Participants
|
46 participants
n=7 Participants
|
47 participants
n=31 Participants
|
48 participants
n=30 Participants
|
289 participants
n=3 Participants
|
|
Age, Customized
Between 30 and 39 years
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
16 participants
n=206 Participants
|
18 participants
n=7 Participants
|
19 participants
n=31 Participants
|
16 participants
n=30 Participants
|
109 participants
n=3 Participants
|
|
Age, Customized
>= 40 years
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
2 participants
n=31 Participants
|
1 participants
n=30 Participants
|
7 participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
71 Participants
n=31 Participants
|
68 Participants
n=30 Participants
|
422 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
Haiti
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
10 participants
n=206 Participants
|
7 participants
n=7 Participants
|
9 participants
n=31 Participants
|
9 participants
n=30 Participants
|
58 participants
n=3 Participants
|
|
Region of Enrollment
Tanzania
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
2 participants
n=31 Participants
|
2 participants
n=30 Participants
|
14 participants
n=3 Participants
|
|
Region of Enrollment
Uganda
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
18 participants
n=206 Participants
|
17 participants
n=7 Participants
|
17 participants
n=31 Participants
|
16 participants
n=30 Participants
|
101 participants
n=3 Participants
|
|
Region of Enrollment
South Africa
|
13 participants
n=99 Participants
|
8 participants
n=107 Participants
|
10 participants
n=206 Participants
|
9 participants
n=7 Participants
|
10 participants
n=31 Participants
|
10 participants
n=30 Participants
|
60 participants
n=3 Participants
|
|
Region of Enrollment
Malawi
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
14 participants
n=206 Participants
|
12 participants
n=7 Participants
|
17 participants
n=31 Participants
|
15 participants
n=30 Participants
|
85 participants
n=3 Participants
|
|
Region of Enrollment
India
|
15 participants
n=99 Participants
|
18 participants
n=107 Participants
|
20 participants
n=206 Participants
|
19 participants
n=7 Participants
|
16 participants
n=31 Participants
|
16 participants
n=30 Participants
|
104 participants
n=3 Participants
|
|
Gestational age at NVP dosing, Continuous
|
38 weeks
STANDARD_DEVIATION 2 • n=99 Participants
|
39 weeks
STANDARD_DEVIATION 2 • n=107 Participants
|
38 weeks
STANDARD_DEVIATION 2 • n=206 Participants
|
38 weeks
STANDARD_DEVIATION 3 • n=7 Participants
|
38 weeks
STANDARD_DEVIATION 2 • n=31 Participants
|
38 weeks
STANDARD_DEVIATION 2 • n=30 Participants
|
38 weeks
STANDARD_DEVIATION 2 • n=3 Participants
|
|
Screening CD4 count Categorical
250-349 cells/mm^3
|
15 participants
n=99 Participants
|
7 participants
n=107 Participants
|
8 participants
n=206 Participants
|
6 participants
n=7 Participants
|
20 participants
n=31 Participants
|
13 participants
n=30 Participants
|
69 participants
n=3 Participants
|
|
Screening CD4 count Categorical
350-499 cells/mm^3
|
24 participants
n=99 Participants
|
21 participants
n=107 Participants
|
29 participants
n=206 Participants
|
29 participants
n=7 Participants
|
25 participants
n=31 Participants
|
22 participants
n=30 Participants
|
150 participants
n=3 Participants
|
|
Screening CD4 count Categorical
>=500 cells/mm^3
|
34 participants
n=99 Participants
|
40 participants
n=107 Participants
|
38 participants
n=206 Participants
|
32 participants
n=7 Participants
|
26 participants
n=31 Participants
|
33 participants
n=30 Participants
|
203 participants
n=3 Participants
|
|
Screening CD4 count Continuous
|
538 cells/mm^3
STANDARD_DEVIATION 244 • n=99 Participants
|
585 cells/mm^3
STANDARD_DEVIATION 215 • n=107 Participants
|
537 cells/mm^3
STANDARD_DEVIATION 186 • n=206 Participants
|
545 cells/mm^3
STANDARD_DEVIATION 191 • n=7 Participants
|
505 cells/mm^3
STANDARD_DEVIATION 205 • n=31 Participants
|
566 cells/mm^3
STANDARD_DEVIATION 249 • n=30 Participants
|
545 cells/mm^3
STANDARD_DEVIATION 216 • n=3 Participants
|
|
Screening HIV-1 RNA Categorical
<=400 copies/mL
|
17 participants
n=99 Participants
|
13 participants
n=107 Participants
|
13 participants
n=206 Participants
|
12 participants
n=7 Participants
|
12 participants
n=31 Participants
|
16 participants
n=30 Participants
|
83 participants
n=3 Participants
|
|
Screening HIV-1 RNA Categorical
401-999 copies/mL
|
12 participants
n=99 Participants
|
8 participants
n=107 Participants
|
7 participants
n=206 Participants
|
11 participants
n=7 Participants
|
6 participants
n=31 Participants
|
4 participants
n=30 Participants
|
48 participants
n=3 Participants
|
|
Screening HIV-1 RNA Categorical
1000-9999 copies/mL
|
17 participants
n=99 Participants
|
26 participants
n=107 Participants
|
33 participants
n=206 Participants
|
25 participants
n=7 Participants
|
29 participants
n=31 Participants
|
18 participants
n=30 Participants
|
148 participants
n=3 Participants
|
|
Screening HIV-1 RNA Categorical
10000-99999 copies/mL
|
17 participants
n=99 Participants
|
17 participants
n=107 Participants
|
18 participants
n=206 Participants
|
14 participants
n=7 Participants
|
20 participants
n=31 Participants
|
26 participants
n=30 Participants
|
112 participants
n=3 Participants
|
|
Screening HIV-1 RNA Categorical
100000-749999 copies/mL
|
8 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
5 participants
n=7 Participants
|
4 participants
n=31 Participants
|
4 participants
n=30 Participants
|
28 participants
n=3 Participants
|
|
Screening HIV-1 RNA Categorical
>=750000 copies/mL
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
1 participants
n=3 Participants
|
|
Screening HIV-1 RNA Categorical
Missing/Unknown
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
2 participants
n=3 Participants
|
|
Screening HIV-1 RNA Continuous
|
3.50 log10 copies/mL
STANDARD_DEVIATION 1.01 • n=99 Participants
|
3.55 log10 copies/mL
STANDARD_DEVIATION 0.90 • n=107 Participants
|
3.54 log10 copies/mL
STANDARD_DEVIATION 0.82 • n=206 Participants
|
3.50 log10 copies/mL
STANDARD_DEVIATION 0.88 • n=7 Participants
|
3.63 log10 copies/mL
STANDARD_DEVIATION 0.90 • n=31 Participants
|
3.66 log10 copies/mL
STANDARD_DEVIATION 0.92 • n=30 Participants
|
3.56 log10 copies/mL
STANDARD_DEVIATION 0.90 • n=3 Participants
|
|
Actual ZDV exposure during pregnancy
yes
|
46 participants
n=99 Participants
|
47 participants
n=107 Participants
|
47 participants
n=206 Participants
|
42 participants
n=7 Participants
|
43 participants
n=31 Participants
|
42 participants
n=30 Participants
|
267 participants
n=3 Participants
|
|
Actual ZDV exposure during pregnancy
no
|
27 participants
n=99 Participants
|
21 participants
n=107 Participants
|
28 participants
n=206 Participants
|
25 participants
n=7 Participants
|
28 participants
n=31 Participants
|
26 participants
n=30 Participants
|
155 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 2 and 6 weeks after completion of treatmentPopulation: 412 women with primary endpoint results available
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint. 10 participants who did not have resistance samples available were excluded from the primary endpoint analysis.
Outcome measures
| Measure |
7-day Lamivudine/Zidovudine (3TC/ZDV)
n=73 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
|
21-day Lamivudine/Zidovudine (3TC/ZDV)
n=67 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
|
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=71 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
|
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=65 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
|
7-day Lopinavir/Ritonavir (LPV/r)
n=71 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
|
21-day Lopinavir/Ritonavir (LPV/r)
n=65 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
|---|---|---|---|---|---|---|
|
Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 and 6 weeks after completion of treatmentFor the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.
Outcome measures
| Measure |
7-day Lamivudine/Zidovudine (3TC/ZDV)
n=73 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
|
21-day Lamivudine/Zidovudine (3TC/ZDV)
n=67 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
|
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=71 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
|
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=65 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
|
7-day Lopinavir/Ritonavir (LPV/r)
n=71 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
|
21-day Lopinavir/Ritonavir (LPV/r)
n=65 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
|---|---|---|---|---|---|---|
|
Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 and 6 weeks after completion of treatmentFor the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.
Outcome measures
| Measure |
7-day Lamivudine/Zidovudine (3TC/ZDV)
n=73 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
|
21-day Lamivudine/Zidovudine (3TC/ZDV)
n=67 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
|
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=71 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
|
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=65 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
|
7-day Lopinavir/Ritonavir (LPV/r)
n=71 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
|
21-day Lopinavir/Ritonavir (LPV/r)
n=65 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
|---|---|---|---|---|---|---|
|
Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From first day of study treatment to week 12Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12. Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death
Outcome measures
| Measure |
7-day Lamivudine/Zidovudine (3TC/ZDV)
n=73 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
|
21-day Lamivudine/Zidovudine (3TC/ZDV)
n=68 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
|
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=75 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
|
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=67 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
|
7-day Lopinavir/Ritonavir (LPV/r)
n=71 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
|
21-day Lopinavir/Ritonavir (LPV/r)
n=68 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
|---|---|---|---|---|---|---|
|
Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12
|
5 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: From first day of study treatment to last day of study treatment (up to 21 days)participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively.
Outcome measures
| Measure |
7-day Lamivudine/Zidovudine (3TC/ZDV)
n=73 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
|
21-day Lamivudine/Zidovudine (3TC/ZDV)
n=68 Participants
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
|
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=75 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
|
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
n=67 Participants
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
|
7-day Lopinavir/Ritonavir (LPV/r)
n=71 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
|
21-day Lopinavir/Ritonavir (LPV/r)
n=63 Participants
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Prematurely
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
5 participants
|
Adverse Events
7-day 3TC/ZDV
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
21-day 3TC/ZDV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
7-day FTC/TDF
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
21-day FTC/TDF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
7-day LPV/r
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
21-day LPV/r
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
7-day 3TC/ZDV
n=73 participants at risk
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV
|
21-day 3TC/ZDV
n=68 participants at risk
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV
|
7-day FTC/TDF
n=75 participants at risk
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF
|
21-day FTC/TDF
n=67 participants at risk
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF
|
7-day LPV/r
n=71 participants at risk
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
|
21-day LPV/r
n=68 participants at risk
SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/73 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/68 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/75 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/67 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/71 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/68 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
|
Injury, poisoning and procedural complications
Uterine rupture
|
1.4%
1/73 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/68 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/75 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/67 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/71 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/68 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.00%
0/73 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/68 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
1.3%
1/75 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/67 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
1.4%
1/71 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/68 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
1.4%
1/73 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/68 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/75 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/67 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/71 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
0.00%
0/68 • From first treatment date to 12 weeks of follow up.
Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".
|
Other adverse events
Adverse event data not reported
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER