Trial Outcomes & Findings for Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART) (NCT NCT02411539)
NCT ID: NCT02411539
Last Updated: 2021-11-05
Results Overview
Refer to detailed description in the protocol section. Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Measured from study treatment initiation to study discontinuation (study duration is 30 weeks)
Results posted on
2021-11-05
Participant Flow
The first participant enrolled to the study on August 25th, 2015 and the last participant enrolled on March 4th, 2016. A total of 13 U.S. sites enrolled participants.
Participant milestones
| Measure |
Arm A: VRC01 Followed by Placebo
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm A: VRC01 Followed by Placebo
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Confounding medical condition
|
0
|
1
|
Baseline Characteristics
Geometric average of screening and entry results. Results were not available for two participants
Baseline characteristics by cohort
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 12 • n=20 Participants
|
52 years
STANDARD_DEVIATION 11 • n=20 Participants
|
48 years
STANDARD_DEVIATION 12 • n=40 Participants
|
|
Age, Customized
18-29 years
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Age, Customized
30-39 years
|
4 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Age, Customized
40-49 years
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Age, Customized
50+ years
|
9 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White non-hispanic
|
13 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black non-hispanic
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic (regardless of race)
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
IV drug history, categorical
Never
|
19 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
IV drug history, categorical
Previously
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
BMI, categorical
Underweight (<18 kg/m^2)
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
BMI, categorical
Normal (18 - <25 kg/m^2)
|
4 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
BMI, categorical
Overweight (25 - <30 kg/m^2)
|
10 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
BMI, categorical
Obese (30+ kg/m^2)
|
5 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Plasma HIV-1 RNA, categorical
< 40 copies/mL
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Plasma HIV-1 RNA, categorical
>= 40 copies/mL
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
CD4+ T-Cell Count, categorical
200 - <350 cells/mm^3
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
CD4+ T-Cell Count, categorical
350 - <500 cells/mm^3
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
CD4+ T-Cell Count, categorical
>= 500 cells/mm^3
|
17 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Creatinine clearance, categorical
50 - 90 mL/min
|
4 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Creatinine clearance, categorical
> 90 mL/min
|
16 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Cell-associated HIV-1 RNA/DNA Ratio
|
-1.35 log10 ratio
n=19 Participants • Geometric average of screening and entry results. Results were not available for two participants
|
-1.51 log10 ratio
n=19 Participants • Geometric average of screening and entry results. Results were not available for two participants
|
-1.45 log10 ratio
n=38 Participants • Geometric average of screening and entry results. Results were not available for two participants
|
PRIMARY outcome
Timeframe: Measured from study treatment initiation to study discontinuation (study duration is 30 weeks)Population: Includes all available follow-up for all participants
Refer to detailed description in the protocol section. Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening, entry and week 6Population: Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells. All participants received at least one dose of the randomized treatment assigned. No participants received the incorrect treatment.
Change from baseline (geometric average of screening and entry results) to week 6 in log10 transformed cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=18 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
|
0.05 log10 ratio
Interval -0.03 to 0.33
|
-0.08 log10 ratio
Interval -0.24 to 0.37
|
SECONDARY outcome
Timeframe: Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12)Population: All participants who received at least one infusion of study treatment
Study treatment was taken from entry through week 12 - this outcome assesses the number of participants who permanently and prematurely discontinued study treatment due to reasons related to the study treatment
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, entry, week 3 and week 6 (week 3 used as LVCF if necessary)Population: Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, carrying last available result forward if missing at week 6
Change from baseline (geometric average of screening and entry results) to week 6 in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, using a last value carried forward approach if week 6 cell-associated HIV-1 RNA/DNA ratio was missing. In the event that the week 6 value was missing, the week 3 value was carried forward to be used. This comparison is the change from the average of screening and entry results to the week 6 value (if available), and if week 6 result was not available, the week 3 value was used instead of the week 6 value.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF)
|
0.06 log10 ratio
Interval -0.03 to 0.53
|
-0.08 log10 ratio
Interval -0.24 to 0.37
|
SECONDARY outcome
Timeframe: Screening, entry and weeks 6 and 12Population: Analysis of all participants with available pre- and post-VRC01 cell-associated RNA/DNA ratio results available. Participants from Arm A must have had results at entry and week 6. Participants from Arm B must have had results from week 6 and week 12.
Summary of within-participant change across treatment arms from the pre-VRC01 time point to the post-VRC01 time point. For Arm A, the pre-VRC01 time point used was the baseline measure (geometric average of screening and entry results) and the post-VRC01 time point was the week 6 measure. For Arm B, the pre-VRC01 time point used was the week 6 measure and the post-VRC01 time point was the week 12 measure. Change in CA-RNA/DNA ratio was calculated on the log10 scale.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=37 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms
|
0.09 log10 ratio
Interval -0.22 to 0.33
|
—
|
SECONDARY outcome
Timeframe: Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis of participants with available cell-associated HIV-1 RNA results
Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Cell-associated HIV-1 RNA in Total CD4+ Cells
Baseline
|
1.60 log10 copies/million CD4
Interval 0.9 to 2.09
|
1.38 log10 copies/million CD4
Interval 0.9 to 2.03
|
|
Cell-associated HIV-1 RNA in Total CD4+ Cells
Week 3
|
1.62 log10 copies/million CD4
Interval 0.87 to 2.09
|
1.56 log10 copies/million CD4
Interval 0.71 to 1.82
|
|
Cell-associated HIV-1 RNA in Total CD4+ Cells
Week 6
|
1.48 log10 copies/million CD4
Interval 1.11 to 2.1
|
1.41 log10 copies/million CD4
Interval 0.99 to 1.9
|
|
Cell-associated HIV-1 RNA in Total CD4+ Cells
Week 9
|
1.56 log10 copies/million CD4
Interval 1.14 to 1.9
|
1.56 log10 copies/million CD4
Interval 0.74 to 1.89
|
|
Cell-associated HIV-1 RNA in Total CD4+ Cells
Week 12
|
1.62 log10 copies/million CD4
Interval 0.73 to 2.03
|
1.51 log10 copies/million CD4
Interval 0.76 to 2.1
|
SECONDARY outcome
Timeframe: Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis of participants with available cell-associated HIV-1 DNA results
Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Cell-associated HIV-1 DNA in Total CD4+ Cells
Baseline
|
3.05 log10 copies/million CD4
Interval 2.42 to 3.2
|
3.00 log10 copies/million CD4
Interval 2.53 to 3.18
|
|
Cell-associated HIV-1 DNA in Total CD4+ Cells
Week 3
|
2.99 log10 copies/million CD4
Interval 2.5 to 3.15
|
2.89 log10 copies/million CD4
Interval 2.61 to 3.0
|
|
Cell-associated HIV-1 DNA in Total CD4+ Cells
Week 6
|
2.99 log10 copies/million CD4
Interval 2.46 to 3.07
|
2.92 log10 copies/million CD4
Interval 2.54 to 3.07
|
|
Cell-associated HIV-1 DNA in Total CD4+ Cells
Week 9
|
2.96 log10 copies/million CD4
Interval 2.46 to 3.23
|
2.91 log10 copies/million CD4
Interval 2.57 to 3.15
|
|
Cell-associated HIV-1 DNA in Total CD4+ Cells
Week 12
|
3.01 log10 copies/million CD4
Interval 2.7 to 3.17
|
2.90 log10 copies/million CD4
Interval 2.55 to 3.12
|
SECONDARY outcome
Timeframe: Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis of participants with available cell-associated HIV-1 RNA/DNA ratio
Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Week 9
|
-1.37 log10 ratio
Interval -1.55 to -1.06
|
-1.40 log10 ratio
Interval -1.8 to -1.02
|
|
Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Baseline
|
-1.35 log10 ratio
Interval -1.63 to -1.02
|
-1.51 log10 ratio
Interval -1.69 to -1.3
|
|
Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Week 3
|
-1.29 log10 ratio
Interval -1.84 to -0.74
|
-1.38 log10 ratio
Interval -1.57 to -1.11
|
|
Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Week 6
|
-1.28 log10 ratio
Interval -1.54 to -0.88
|
-1.44 log10 ratio
Interval -1.78 to -1.19
|
|
Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Week 12
|
-1.42 log10 ratio
Interval -1.8 to -1.04
|
-1.33 log10 ratio
Interval -1.87 to -1.09
|
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis of participants with available SCA results
The analysis of HIV-1 RNA SCA assessed the number of participants below the assay lower limit (1 copy/mL) at each measurement week. Specific specimens and time points were targeted based on Arm. Samples were not tested for Arm A at the Week 7 and Week 10 time points. Samples were not tested for Arm B at the Week 1 and Week 4 time points. Testing of specimens at weeks 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Screening
|
13 Participants
|
12 Participants
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Entry
|
8 Participants
|
10 Participants
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Week 1
|
9 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Week 3
|
9 Participants
|
11 Participants
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Week 4
|
11 Participants
|
—
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Week 6
|
11 Participants
|
12 Participants
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Week 7
|
—
|
11 Participants
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Week 9
|
13 Participants
|
9 Participants
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Week 10
|
—
|
11 Participants
|
|
Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Week 12
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 6, 12, 18 and 30Population: Analysis of all participants with available CD4+ results
Baseline measure represents the average of screening and entry results
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
CD4+ T-cell Counts
Baseline
|
701 cells/mm^3
Interval 594.0 to 952.0
|
685 cells/mm^3
Interval 535.0 to 843.0
|
|
CD4+ T-cell Counts
Week 6
|
709 cells/mm^3
Interval 564.0 to 995.0
|
697 cells/mm^3
Interval 532.0 to 807.0
|
|
CD4+ T-cell Counts
Week 12
|
734 cells/mm^3
Interval 616.0 to 886.0
|
671 cells/mm^3
Interval 513.0 to 873.0
|
|
CD4+ T-cell Counts
Week 18
|
709 cells/mm^3
Interval 529.0 to 885.0
|
672 cells/mm^3
Interval 475.0 to 844.0
|
|
CD4+ T-cell Counts
Week 30
|
750 cells/mm^3
Interval 612.0 to 1025.0
|
712 cells/mm^3
Interval 486.0 to 806.0
|
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 6, 12, 18 and 30Population: Analysis of all participants with available CD8+ results
Baseline measure represents the average of screening and entry results
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
CD8+ T-cell Counts
Baseline
|
801 cells/mm^3
Interval 490.0 to 1210.0
|
617 cells/mm^3
Interval 480.0 to 744.0
|
|
CD8+ T-cell Counts
Week 6
|
688 cells/mm^3
Interval 469.0 to 977.0
|
614 cells/mm^3
Interval 481.0 to 825.0
|
|
CD8+ T-cell Counts
Week 12
|
649 cells/mm^3
Interval 508.0 to 1039.0
|
620 cells/mm^3
Interval 439.0 to 852.0
|
|
CD8+ T-cell Counts
Week 18
|
766 cells/mm^3
Interval 495.0 to 1214.0
|
665 cells/mm^3
Interval 421.0 to 766.0
|
|
CD8+ T-cell Counts
Week 30
|
731 cells/mm^3
Interval 551.0 to 990.0
|
655 cells/mm^3
Interval 436.0 to 740.0
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6 and week 12Population: Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay
As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Total/Inducible Virus Recovery - Stimulated HIV-1 RNA
Pre-entry
|
2.83 log10 copies/mL
Interval 1.81 to 3.16
|
2.85 log10 copies/mL
Interval 2.28 to 3.49
|
|
Total/Inducible Virus Recovery - Stimulated HIV-1 RNA
Week 6
|
2.74 log10 copies/mL
Interval 2.31 to 3.41
|
3.12 log10 copies/mL
Interval 2.11 to 3.54
|
|
Total/Inducible Virus Recovery - Stimulated HIV-1 RNA
Week 12
|
2.74 log10 copies/mL
Interval 2.53 to 3.18
|
2.63 log10 copies/mL
Interval 2.27 to 3.47
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6 and week 12Population: Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay
As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA
Week 6
|
1.44 log10 copies/mL
Interval 0.71 to 1.95
|
0.92 log10 copies/mL
Interval 0.0 to 1.61
|
|
Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA
Pre-entry
|
1.00 log10 copies/mL
Interval 0.5 to 1.86
|
1.00 log10 copies/mL
Interval 0.0 to 1.81
|
|
Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA
Week 12
|
1.25 log10 copies/mL
Interval 0.5 to 1.9
|
1.53 log10 copies/mL
Interval 1.0 to 2.01
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6 and week 12Population: Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay
As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio
Pre-entry
|
16.73 ratio
Interval 4.76 to 104.29
|
25.49 ratio
Interval 8.12 to 115.48
|
|
Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio
Week 6
|
21.03 ratio
Interval 5.58 to 78.37
|
40.50 ratio
Interval 10.77 to 759.42
|
|
Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio
Week 12
|
34.12 ratio
Interval 5.57 to 93.9
|
16.09 ratio
Interval 9.0 to 43.11
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6 and week 12Population: Includes all participants with available stimulated cell fluor results from virus recovery assay
As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Total/Inducible Virus Recovery - Stimulated Cell Fluor
Pre-entry
|
25.86 million light units
Interval 22.14 to 30.42
|
26.05 million light units
Interval 21.42 to 30.09
|
|
Total/Inducible Virus Recovery - Stimulated Cell Fluor
Week 6
|
24.68 million light units
Interval 22.0 to 30.09
|
26.13 million light units
Interval 21.79 to 29.81
|
|
Total/Inducible Virus Recovery - Stimulated Cell Fluor
Week 12
|
27.38 million light units
Interval 22.12 to 31.25
|
26.97 million light units
Interval 22.57 to 32.01
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6 and week 12Population: Includes all participants with available unstimulated cell fluor results from virus recovery assay
As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Total/Inducible Virus Recovery - Unstimulated Cell Fluor
Pre-entry
|
6.86 million light units
Interval 5.7 to 13.34
|
5.87 million light units
Interval 4.57 to 6.93
|
|
Total/Inducible Virus Recovery - Unstimulated Cell Fluor
Week 6
|
6.39 million light units
Interval 4.94 to 8.01
|
6.22 million light units
Interval 5.0 to 8.76
|
|
Total/Inducible Virus Recovery - Unstimulated Cell Fluor
Week 12
|
8.53 million light units
Interval 6.2 to 12.16
|
6.27 million light units
Interval 5.05 to 8.38
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6 and week 12Population: Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay
As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio
Pre-entry
|
2.91 ratio
Interval 2.14 to 4.65
|
4.32 ratio
Interval 3.6 to 5.13
|
|
Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio
Week 6
|
4.20 ratio
Interval 3.04 to 4.78
|
3.87 ratio
Interval 3.36 to 5.49
|
|
Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio
Week 12
|
3.33 ratio
Interval 2.16 to 4.62
|
3.76 ratio
Interval 3.52 to 4.38
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6 and week 12Population: Includes all participants with available %tCD4 yield results from virus recovery assay
As part of the total virus recovery assay, results for %tCD4 yield are generated.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Total/Inducible Virus Recovery - Percentage of Total CD4 Yield
Pre-entry
|
25.35 percentage of Total CD4 Yield
Interval 20.0 to 32.17
|
22.00 percentage of Total CD4 Yield
Interval 19.0 to 27.0
|
|
Total/Inducible Virus Recovery - Percentage of Total CD4 Yield
Week 6
|
25.00 percentage of Total CD4 Yield
Interval 18.0 to 32.14
|
22.38 percentage of Total CD4 Yield
Interval 17.65 to 33.33
|
|
Total/Inducible Virus Recovery - Percentage of Total CD4 Yield
Week 12
|
25.00 percentage of Total CD4 Yield
Interval 21.0 to 30.32
|
22.58 percentage of Total CD4 Yield
Interval 18.81 to 29.0
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6Population: Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points
As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA
|
0.74 fold change
Interval 0.31 to 8.38
|
1.32 fold change
Interval 0.3 to 1.99
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6Population: Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points
As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA
|
1.37 fold change
Interval 1.0 to 2.11
|
1.00 fold change
Interval 0.19 to 2.42
|
SECONDARY outcome
Timeframe: Measured at pre-entry and week 6Population: Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay
As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio
|
0.69 fold change
Interval 0.2 to 3.71
|
0.85 fold change
Interval 0.21 to 12.38
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6Population: Includes all participants with available stimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor
|
0.97 fold change
Interval 0.91 to 1.09
|
0.97 fold change
Interval 0.92 to 1.05
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6Population: Includes all participants with available unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor
|
0.93 fold change
Interval 0.66 to 1.15
|
1.12 fold change
Interval 1.02 to 1.39
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6Population: Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio
|
1.08 fold change
Interval 0.84 to 1.64
|
0.85 fold change
Interval 0.73 to 1.08
|
SECONDARY outcome
Timeframe: Measured at pre-entry, week 6Population: Includes all participants with available %tCD4 yield results from virus recovery assay at pre-entry and week 6 time points
As part of the total virus recovery assay, results for %tCD4 yield are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield
|
1.00 fold change
Interval 0.81 to 1.41
|
1.06 fold change
Interval 0.77 to 1.27
|
SECONDARY outcome
Timeframe: Measured at entry and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 and 30Population: Analysis of all participants with available results.
Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up Specific specimens and time points were targeted for testing based on Arm. Samples for Arm A were not tested for the Week 6 and Week 9 post-infusion time points. Samples for Arm B were not tested for the Week 0 and Week 3 post-infusion time points.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
VRC01 Antibody Level
Week 0 - Pre-Infusion
|
0.1 ug/mL
Interval 0.1 to 0.1
|
0.1 ug/mL
Interval 0.1 to 0.1
|
|
VRC01 Antibody Level
Week 0 - Post-Infusion
|
1726.2 ug/mL
Interval 1492.5 to 1950.3
|
—
|
|
VRC01 Antibody Level
Week 1
|
259.9 ug/mL
Interval 213.0 to 297.5
|
0.1 ug/mL
Interval 0.1 to 0.1
|
|
VRC01 Antibody Level
Week 2
|
147.4 ug/mL
Interval 123.3 to 182.1
|
0.1 ug/mL
Interval 0.1 to 0.1
|
|
VRC01 Antibody Level
Week 3 - Pre-Infusion
|
113.6 ug/mL
Interval 102.2 to 130.0
|
0.1 ug/mL
Interval 0.1 to 0.1
|
|
VRC01 Antibody Level
Week 3 - Post-Infusion
|
1807.7 ug/mL
Interval 1617.0 to 2105.5
|
—
|
|
VRC01 Antibody Level
Week 4
|
361.9 ug/mL
Interval 295.4 to 432.3
|
0.1 ug/mL
Interval 0.1 to 0.1
|
|
VRC01 Antibody Level
Week 5
|
216.9 ug/mL
Interval 174.6 to 254.2
|
0.1 ug/mL
Interval 0.1 to 0.1
|
|
VRC01 Antibody Level
Week 6 - Pre-Infusion
|
135.8 ug/mL
Interval 112.2 to 164.5
|
0.1 ug/mL
Interval 0.1 to 0.1
|
|
VRC01 Antibody Level
Week 6 - Post-Infusion
|
—
|
1643.5 ug/mL
Interval 1483.3 to 2041.5
|
|
VRC01 Antibody Level
Week 7
|
95.9 ug/mL
Interval 63.4 to 119.2
|
277.7 ug/mL
Interval 240.7 to 318.2
|
|
VRC01 Antibody Level
Week 8
|
56.2 ug/mL
Interval 35.5 to 82.7
|
158.0 ug/mL
Interval 126.6 to 193.5
|
|
VRC01 Antibody Level
Week 9 - Pre-Infusion
|
42.1 ug/mL
Interval 21.1 to 56.8
|
98.7 ug/mL
Interval 82.8 to 167.1
|
|
VRC01 Antibody Level
Week 9 - Post-Infusion
|
—
|
1717.8 ug/mL
Interval 1446.9 to 2153.0
|
|
VRC01 Antibody Level
Week 10
|
37.8 ug/mL
Interval 27.6 to 47.4
|
373.8 ug/mL
Interval 302.3 to 416.0
|
|
VRC01 Antibody Level
Week 11
|
19.3 ug/mL
Interval 10.4 to 28.1
|
217.2 ug/mL
Interval 178.0 to 301.2
|
|
VRC01 Antibody Level
Week 12
|
13.4 ug/mL
Interval 6.3 to 25.1
|
131.1 ug/mL
Interval 106.3 to 215.3
|
|
VRC01 Antibody Level
Week 15
|
5.0 ug/mL
Interval 1.9 to 10.9
|
42.1 ug/mL
Interval 30.6 to 66.6
|
|
VRC01 Antibody Level
Week 18
|
2.1 ug/mL
Interval 0.1 to 5.2
|
18.3 ug/mL
Interval 9.0 to 45.6
|
|
VRC01 Antibody Level
Week 30
|
0.1 ug/mL
Interval 0.1 to 0.1
|
0.1 ug/mL
Interval 0.1 to 0.1
|
SECONDARY outcome
Timeframe: Measured at week 30Population: All participants with results for anti-VRC01 antibody. Two participants did not have results (one from each arm) due to being lost to follow up.
Assess the detectability of antibody to VRC01 in samples collected during study follow-up. Intended to be result from specimen at week 30 time point. Due to specimen availability, four participants in Arm A had results from specimens from the week 18 time point. Counts provided are number of participants with detectable anti-VRC01 antibody result.
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=19 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=19 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Detectability of Antibody to VRC01 as Measured in Serum
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis not performed. See outcome measure description for reasoning.
% CD4+ and CD8+ T-cells co-expressing human leukocyte antigen (HLA)-DR and CD38 Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis not performed. See outcome measure description for reasoning.
% NK cells expressing CD69 or CD95 Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis not performed. See outcome measure description for reasoning.
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis not performed. See outcome measure description for reasoning.
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis not performed. See outcome measure description for reasoning.
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis not performed. See outcome measure description for reasoning.
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis not performed. See outcome measure description for reasoning.
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30Population: Analysis not performed. See outcome measure description for reasoning.
Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured immediately after first infusion (and 1, 2, and 3 weeks after), and immediately after second infusion (and 1, 2, 3, 6 and 9 weeks after)Population: Analysis of all participants with available results.
Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up - aligning the timing of PK samples/results to the respective VRC01 infusions for each Arm
Outcome measures
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 Participants
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 Participants
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
VRC01 Antibody Level Relative to Infusion Timing
First dose - Post-Infusion
|
1726.2 ug/mL
Interval 1492.5 to 1950.3
|
1643.5 ug/mL
Interval 1483.3 to 2041.5
|
|
VRC01 Antibody Level Relative to Infusion Timing
One week after first infusion
|
259.9 ug/mL
Interval 213.0 to 297.5
|
277.7 ug/mL
Interval 240.7 to 318.2
|
|
VRC01 Antibody Level Relative to Infusion Timing
Two weeks after first infusion
|
147.4 ug/mL
Interval 123.3 to 182.1
|
158.0 ug/mL
Interval 126.6 to 193.5
|
|
VRC01 Antibody Level Relative to Infusion Timing
Three weeks after first infusion
|
113.6 ug/mL
Interval 102.2 to 130.0
|
98.7 ug/mL
Interval 82.8 to 167.1
|
|
VRC01 Antibody Level Relative to Infusion Timing
Second dose - Post-infusion
|
1807.7 ug/mL
Interval 1617.0 to 2105.5
|
1717.8 ug/mL
Interval 1446.9 to 2153.0
|
|
VRC01 Antibody Level Relative to Infusion Timing
One week after second infusion
|
361.9 ug/mL
Interval 295.4 to 432.3
|
373.8 ug/mL
Interval 302.3 to 416.0
|
|
VRC01 Antibody Level Relative to Infusion Timing
Two weeks after second infusion
|
216.9 ug/mL
Interval 174.6 to 254.2
|
217.2 ug/mL
Interval 178.0 to 301.2
|
|
VRC01 Antibody Level Relative to Infusion Timing
Three weeks after second infusion
|
135.8 ug/mL
Interval 112.2 to 164.5
|
131.1 ug/mL
Interval 106.3 to 215.3
|
|
VRC01 Antibody Level Relative to Infusion Timing
Six weeks after second infusion
|
42.1 ug/mL
Interval 21.1 to 56.8
|
42.1 ug/mL
Interval 30.6 to 66.6
|
|
VRC01 Antibody Level Relative to Infusion Timing
Nine weeks after second infusion
|
13.4 ug/mL
Interval 6.3 to 25.1
|
18.3 ug/mL
Interval 9.0 to 45.6
|
Adverse Events
Arm A: VRC01 Followed by Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm B: Placebo Followed by VRC01
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 participants at risk
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 participants at risk
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
Other adverse events
| Measure |
Arm A: VRC01 Followed by Placebo
n=20 participants at risk
Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
Arm B: Placebo Followed by VRC01
n=20 participants at risk
Participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9.
VRC01: 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump Placebo: Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
15.0%
3/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Gastrointestinal disorders
Reactive gastropathy
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
General disorders
Chest discomfort
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
General disorders
Chest pain
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
General disorders
Chills
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
General disorders
Fatigue
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
General disorders
Influenza like illness
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
General disorders
Malaise
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
General disorders
Pain
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
General disorders
Pyrexia
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Alanine aminotransferase
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Aspartate aminotransferase
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Bilirubin conjugated abnormal
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Bilirubin conjugated increased
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood alkaline phosphatase abnormal
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood bilirubin abnormal
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood creatinine abnormal
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
15.0%
3/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood creatinine increased
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
15.0%
3/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood glucose increased
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood potassium decreased
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood potassium increased
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Blood sodium decreased
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Creatinine renal clearance decreased
|
30.0%
6/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
50.0%
10/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Haemoglobin decreased
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Psychiatric disorders
Psychogenic seizure
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Reproductive system and breast disorders
Genital lesion
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
20.0%
4/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
15.0%
3/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Skin and subcutaneous tissue disorders
Fixed drug eruption
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
|
Vascular disorders
Hot flush
|
0.00%
0/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
5.0%
1/20 • From first infusion through end of study follow up (the duration of the study is 30 weeks)
The SAE Reporting Category, as defined in Version 2.0 of the DAIDS EAE Manual, was used for this study. At entry, signs, symptoms and laboratory values regardless of grade were reported. Post-entry, signs, symptoms and laboratory values grade ≥2, or those causing a change in treatment/ART, regardless of grade, were reported. Diagnoses identified on the study-specific list of diagnoses were recorded at entry and at all subsequent visits. Used DAIDS AE Grading Table, Version 2.0, November 2014
|
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
- Publication restrictions are in place