Trial Outcomes & Findings for Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected (NCT NCT01632891)
NCT ID: NCT01632891
Last Updated: 2019-08-06
Results Overview
Pf SCP clearance defined by polymerase chain reaction (PCR) \< 10 parasites/µL on three consecutive occasions within a 24-hour period. If a participant had missing data on day 15, they were considered as not having clearance.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Day 15 (3 samples collected, separated by at least 5 hours and all three collected within 24-hours)
Results posted on
2019-08-06
Participant Flow
Participants were recruited from 5 clinics in Africa. The first participant enrolled on January 10, 2014. The last participant enrolled on May 20, 2016.
Participant milestones
| Measure |
LPV/R-based ART
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
LPV/R-based ART
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected
Baseline characteristics by cohort
| Measure |
LPV/R-based ART
n=26 Participants
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
n=26 Participants
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
n=99 Participants
|
31 years
n=107 Participants
|
31 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Region of Enrollment
Malawi
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Uganda
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Kenya
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
CD4 cell count
|
360 cells/mm^3
n=99 Participants
|
302 cells/mm^3
n=107 Participants
|
324 cells/mm^3
n=206 Participants
|
|
Log10(HIV-1 RNA)
|
5.11 Log10(cp/ml)
n=99 Participants
|
5.37 Log10(cp/ml)
n=107 Participants
|
5.18 Log10(cp/ml)
n=206 Participants
|
|
Log10(parasite density)
|
2.69 Log10(parasites/µL)
n=99 Participants
|
2.50 Log10(parasites/µL)
n=107 Participants
|
2.66 Log10(parasites/µL)
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 15 (3 samples collected, separated by at least 5 hours and all three collected within 24-hours)Population: Primary analysis is based on intent-to-treat principles and includes all randomized participants.
Pf SCP clearance defined by polymerase chain reaction (PCR) \< 10 parasites/µL on three consecutive occasions within a 24-hour period. If a participant had missing data on day 15, they were considered as not having clearance.
Outcome measures
| Measure |
LPV/R-based ART
n=26 Participants
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
n=26 Participants
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
LPV/R-based ART, Not Cleared
Randomized to LPV/r based ART with continued Pf SCP at day 15
|
LPV/R-based ART, Cleared
Randomized to LPV/r based ART with clearance of Pf SCP at day 15
|
|---|---|---|---|---|
|
Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance
Proportion Cleared
|
0.23 Proportion of participants
|
0.27 Proportion of participants
|
—
|
—
|
|
Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance
Proportion Not Cleared
|
0.77 Proportion of participants
|
0.73 Proportion of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry up to day 30Population: Analysis only includes participants who received 15 days of treatment, excluding one participant on LPV/r-based ART. One participant on nNRTI-based ART had missing data at all time points.
Time to clearance is defined by time to first measurement with PCR \< 10 parasites/µL, and is evaluated as the point estimate and 95% CI for the day when 50% of participants cleared parasite.
Outcome measures
| Measure |
LPV/R-based ART
n=25 Participants
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
n=25 Participants
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
LPV/R-based ART, Not Cleared
Randomized to LPV/r based ART with continued Pf SCP at day 15
|
LPV/R-based ART, Cleared
Randomized to LPV/r based ART with clearance of Pf SCP at day 15
|
|---|---|---|---|---|
|
Time to First Pf SCP Clearance
|
12 Days
Interval 5.0 to 29.0
|
14 Days
Interval 2.0 to 29.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Entry, days 3, 6, 9, 12, 15, 20, 25, 30Population: Analysis only includes participants who received 15 days of treatment, excluding one participant on LPV/r-based ART. One participant on nNRTI-based ART had missing data at all time points. Several samples were missing at various time points, as shown by number of participants for each day.
Pf parasite density was determined by PCR. If parasite density equals 0, the value is set to 0.01 before log10 transformation. The value 0.01 was chosen based on the smallest observed parasite density value of 0.017.
Outcome measures
| Measure |
LPV/R-based ART
n=25 Participants
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
n=25 Participants
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
LPV/R-based ART, Not Cleared
Randomized to LPV/r based ART with continued Pf SCP at day 15
|
LPV/R-based ART, Cleared
Randomized to LPV/r based ART with clearance of Pf SCP at day 15
|
|---|---|---|---|---|
|
Log10(Pf Parasite Density)
Entry
|
2.48 log10(parasites/µL)
Interval 1.93 to 3.02
|
2.09 log10(parasites/µL)
Interval 1.32 to 2.85
|
—
|
—
|
|
Log10(Pf Parasite Density)
Day 3
|
1.92 log10(parasites/µL)
Interval 1.4 to 2.44
|
1.57 log10(parasites/µL)
Interval 0.77 to 2.37
|
—
|
—
|
|
Log10(Pf Parasite Density)
Day 6
|
1.77 log10(parasites/µL)
Interval 1.24 to 2.29
|
1.49 log10(parasites/µL)
Interval 0.65 to 2.33
|
—
|
—
|
|
Log10(Pf Parasite Density)
Day 9
|
1.65 log10(parasites/µL)
Interval 1.03 to 2.27
|
1.63 log10(parasites/µL)
Interval 0.85 to 2.41
|
—
|
—
|
|
Log10(Pf Parasite Density)
Day 12
|
1.59 log10(parasites/µL)
Interval 0.99 to 2.19
|
1.56 log10(parasites/µL)
Interval 0.66 to 2.46
|
—
|
—
|
|
Log10(Pf Parasite Density)
Day 15
|
1.59 log10(parasites/µL)
Interval 1.0 to 2.18
|
1.43 log10(parasites/µL)
Interval 0.63 to 2.23
|
—
|
—
|
|
Log10(Pf Parasite Density)
Day 20
|
0.65 log10(parasites/µL)
Interval 0.05 to 1.25
|
0.67 log10(parasites/µL)
Interval -0.19 to 1.52
|
—
|
—
|
|
Log10(Pf Parasite Density)
Day 25
|
0.28 log10(parasites/µL)
Interval -0.42 to 0.99
|
0.49 log10(parasites/µL)
Interval -0.36 to 1.33
|
—
|
—
|
|
Log10(Pf Parasite Density)
Day 30
|
0.14 log10(parasites/µL)
Interval -0.51 to 0.79
|
0.30 log10(parasites/µL)
Interval -0.35 to 0.95
|
—
|
—
|
SECONDARY outcome
Timeframe: Entry, Day 30Population: All participants enrolled with results available at entry and day 30: 3 participants were missing data in 'nNRTI-based ART, not cleared' group. 1 participant was missing data in 'nNRTI-based ART, cleared' group. 1 participant was missing data in 'LPV/r-based ART, not cleared' group.
Change is evaluated as log10(Pf parasite density) at day 30 minus log10(Pf parasite density) at entry. Change is evaluated in four groups: * Randomized to nNRTI-based ART with continued Pf SCP at day 15 * Randomized to nNRTI-based ART with clearance of Pf SCP at day 15 * Randomized to LPV/r-based ART with continued Pf SCP at day 15 * Randomized to LPV/r-based ART with clearance of Pf SCP at day 15
Outcome measures
| Measure |
LPV/R-based ART
n=16 Participants
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
n=6 Participants
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
LPV/R-based ART, Not Cleared
n=19 Participants
Randomized to LPV/r based ART with continued Pf SCP at day 15
|
LPV/R-based ART, Cleared
n=6 Participants
Randomized to LPV/r based ART with clearance of Pf SCP at day 15
|
|---|---|---|---|---|
|
Change in log10(Pf Parasite Density) From Entry to Day 30
|
-2.26 log10(parasites/µL)
Interval -3.3 to -1.29
|
-1.65 log10(parasites/µL)
Interval -3.39 to 0.4
|
-1.82 log10(parasites/µL)
Interval -3.65 to -0.39
|
-3.61 log10(parasites/µL)
Interval -4.96 to -2.19
|
SECONDARY outcome
Timeframe: From study entry to day 30Population: All participants.
Uncomplicated clinical malaria is defined as the presence of non-severe fever/symptoms and parasitemia without organ complication.
Outcome measures
| Measure |
LPV/R-based ART
n=26 Participants
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
n=26 Participants
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
LPV/R-based ART, Not Cleared
Randomized to LPV/r based ART with continued Pf SCP at day 15
|
LPV/R-based ART, Cleared
Randomized to LPV/r based ART with clearance of Pf SCP at day 15
|
|---|---|---|---|---|
|
Number of Participants With Uncomplicated Clinical Malaria
|
2 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Entry, days 3, 6, 9, 12, 15, 20, 25, 30Population: Analysis only includes participants who received 15 days of treatment, excluding one participant on LPV/r-based ART. One other participant on LPV/r-based ART had missing data at all time points. Several samples were missing at various time points, as shown by number of participants for each day.
Number of participants with detectable Pf gametocyte density as determined by PCR. Due to the large number of undetectable results, this outcome was measured as dichotomous.
Outcome measures
| Measure |
LPV/R-based ART
n=24 Participants
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
n=26 Participants
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
LPV/R-based ART, Not Cleared
Randomized to LPV/r based ART with continued Pf SCP at day 15
|
LPV/R-based ART, Cleared
Randomized to LPV/r based ART with clearance of Pf SCP at day 15
|
|---|---|---|---|---|
|
Number of Participants With Detectable Pf Gametocyte Density
Entry
|
11 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants With Detectable Pf Gametocyte Density
Day 3
|
10 Participants
|
15 Participants
|
—
|
—
|
|
Number of Participants With Detectable Pf Gametocyte Density
Day 6
|
9 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants With Detectable Pf Gametocyte Density
Day 9
|
11 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants With Detectable Pf Gametocyte Density
Day 12
|
6 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants With Detectable Pf Gametocyte Density
Day 15
|
10 Participants
|
14 Participants
|
—
|
—
|
|
Number of Participants With Detectable Pf Gametocyte Density
Day 20
|
11 Participants
|
14 Participants
|
—
|
—
|
|
Number of Participants With Detectable Pf Gametocyte Density
Day 25
|
12 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Detectable Pf Gametocyte Density
Day 30
|
11 Participants
|
13 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Entry, Day 30Population: All participants with results available at both entry and day 30 who did not have Pf SCP clearance at day 15. 1. participant was missing from the nNRTI-based ART, not cleared group 2. participants were missing from the LPV/r-based ART, not cleared group
Change in log10(Pf gametocyte density) as evaluated using a Hodges-Lehmann estimate from entry to day 30 is evaluated in two groups: * Randomized to nNRTI-based ART with continued Pf SCP at day 15 * Randomized to LPV/r-based ART with continued Pf SCP at day 15 Analysis was not conducted in either group with clearance at day 15 due to the small sample size and high number of undetectable samples in both clearance groups at entry and day 30.
Outcome measures
| Measure |
LPV/R-based ART
n=18 Participants
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
LPV/R-based ART, Not Cleared
n=18 Participants
Randomized to LPV/r based ART with continued Pf SCP at day 15
|
LPV/R-based ART, Cleared
Randomized to LPV/r based ART with clearance of Pf SCP at day 15
|
|---|---|---|---|---|
|
Change in log10(Pf Gametocyte Density) From Entry to Day 30
|
-0.46 log10(gametocyte/µL)
Interval -1.33 to 0.2
|
—
|
0.17 log10(gametocyte/µL)
Interval -0.75 to 0.89
|
—
|
Adverse Events
LPV/R-based ART
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
nNRTI-based ART
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LPV/R-based ART
n=26 participants at risk
Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
nNRTI-based ART
n=26 participants at risk
Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
3.8%
1/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
|
General disorders
Fatigue
|
7.7%
2/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
3.8%
1/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
|
Infections and infestations
Plasmodium falciparum infection
|
7.7%
2/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
3.8%
1/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
2/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
3.8%
1/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
7.7%
2/26 • From randomization to study completion at 30 days
The following adverse event information was collected: * Signs and symptoms Grade ≥ 3, and signs and symptoms that led to a change in treatment regardless of grade * All laboratory values Grade ≥ 2, and laboratory values that led to a change in treatment regardless of grade * All diagnoses identified by ACTG criteria for clinical events and other diseases * Deaths Grading performed according to DAIDS AE Grading Table (V1.0). SAEs defined in EAE Manual (V2.0). Refer to Protocol Section 11.
|
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