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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02411539
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : July 31, 2017
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Biological: VRC01
Biological: Placebo
Enrollment 40
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 20 20
Completed 18 19
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             0
Confounding medical condition             0             1
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01 Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
All participants enrolled
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
44  (12) 52  (11) 48  (12)
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
18-29 years Number Analyzed 20 participants 20 participants 40 participants
3
  15.0%
2
  10.0%
5
  12.5%
30-39 years Number Analyzed 20 participants 20 participants 40 participants
4
  20.0%
1
   5.0%
5
  12.5%
40-49 years Number Analyzed 20 participants 20 participants 40 participants
4
  20.0%
2
  10.0%
6
  15.0%
50+ years Number Analyzed 20 participants 20 participants 40 participants
9
  45.0%
15
  75.0%
24
  60.0%
[1]
Measure Description: Age at enrollment, categorized
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
3
  15.0%
0
   0.0%
3
   7.5%
Male
17
  85.0%
20
 100.0%
37
  92.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White non-hispanic Number Analyzed 20 participants 20 participants 40 participants
13
  65.0%
14
  70.0%
27
  67.5%
Black non-hispanic Number Analyzed 20 participants 20 participants 40 participants
3
  15.0%
4
  20.0%
7
  17.5%
Hispanic (regardless of race) Number Analyzed 20 participants 20 participants 40 participants
4
  20.0%
2
  10.0%
6
  15.0%
IV drug history, categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Never Number Analyzed 20 participants 20 participants 40 participants
19
  95.0%
18
  90.0%
37
  92.5%
Previously Number Analyzed 20 participants 20 participants 40 participants
1
   5.0%
2
  10.0%
3
   7.5%
BMI, categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Underweight (<18 kg/m^2) Number Analyzed 20 participants 20 participants 40 participants
1
   5.0%
0
   0.0%
1
   2.5%
Normal (18 - <25 kg/m^2) Number Analyzed 20 participants 20 participants 40 participants
4
  20.0%
11
  55.0%
15
  37.5%
Overweight (25 - <30 kg/m^2) Number Analyzed 20 participants 20 participants 40 participants
10
  50.0%
6
  30.0%
16
  40.0%
Obese (30+ kg/m^2) Number Analyzed 20 participants 20 participants 40 participants
5
  25.0%
3
  15.0%
8
  20.0%
[1]
Measure Description: Categories from entry visit
Plasma HIV-1 RNA, categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
< 40 copies/mL Number Analyzed 20 participants 20 participants 40 participants
20
 100.0%
20
 100.0%
40
 100.0%
>= 40 copies/mL Number Analyzed 20 participants 20 participants 40 participants
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Categorization of the result from the entry visit
CD4+ T-Cell Count, categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
200 - <350 cells/mm^3 Number Analyzed 20 participants 20 participants 40 participants
0
   0.0%
2
  10.0%
2
   5.0%
350 - <500 cells/mm^3 Number Analyzed 20 participants 20 participants 40 participants
3
  15.0%
2
  10.0%
5
  12.5%
>= 500 cells/mm^3 Number Analyzed 20 participants 20 participants 40 participants
17
  85.0%
16
  80.0%
33
  82.5%
[1]
Measure Description: Categorization of the average results from the screening and entry visits
Creatinine clearance, categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
50 - 90 mL/min Number Analyzed 20 participants 20 participants 40 participants
4
  20.0%
9
  45.0%
13
  32.5%
> 90 mL/min Number Analyzed 20 participants 20 participants 40 participants
16
  80.0%
11
  55.0%
27
  67.5%
[1]
Measure Description: Categorization of the average results from the screening and entry visits
Cell-associated HIV-1 RNA/DNA Ratio   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Log10 ratio
Number Analyzed 19 participants 19 participants 38 participants
-1.35
(-1.63 to -1.02)
-1.51
(-1.69 to -1.30)
-1.45
(-1.63 to -1.17)
[1]
Measure Analysis Population Description: Geometric average of screening and entry results. Results were not available for two participants
1.Primary Outcome
Title Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE)
Hide Description

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.

Time Frame Measured from study treatment initiation to study discontinuation (study duration is 30 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all available follow-up for all participants
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Hide Description 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
Time Frame Screening, entry and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 18 19
Median (Inter-Quartile Range)
Unit of Measure: log10 ratio
0.05
(-0.03 to 0.33)
-0.08
(-0.24 to 0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: VRC01 Followed by Placebo, Arm B: Placebo Followed by VRC01
Comments The primary efficacy analysis compared the change in cell-associated HIV-1 RNA/DNA ratio (log-transformed) from baseline to week 6 between the two randomized arms, testing the null hypothesis of no difference in changes in cell-associated HIV-1 RNA/DNA ratio between the two arms using a Wilcoxon rank sum test at 10% significance level.
Type of Statistical Test Superiority
Comments Assuming that a common standard deviation of change (measured as difference of log10 transformed HIV-1 RNA/DNA ratios) in both arms was 0.30, with a sample size of 36 evaluable participants (18 in each arm), the study had 88% power to detect an effect size of 0.30 log10 (2-fold) in change of cell-associated HIV-1 RNA/DNA from baseline to week 6 using a two-sided Wilcoxon rank sum test at 10% type I error rate assuming a normal distribution
Statistical Test of Hypothesis P-Value 0.16
Comments Two-sided Wilcoxon rank sum test at 10% significance level. Not adjusted for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment
Hide Description 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
Time Frame Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one infusion of study treatment
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF)
Hide Description 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.
Time Frame Screening, entry, week 3 and week 6 (week 3 used as LVCF if necessary)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: log10 ratio
0.06
(-0.03 to 0.53)
-0.08
(-0.24 to 0.37)
5.Secondary Outcome
Title Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms
Hide Description 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.
Time Frame Screening, entry and weeks 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Across Arms
Hide Arm/Group Description:
Compare the pre-VRC01 and post-VRC01 time points across randomized Arms A/B. Arm A participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo at Weeks 6 and 9. Arm B participants received an infusion of placebo at Day 0 and Week 3 and an infusion of VRC01 at Weeks 6 and 9. This group is to identify analyses that were assessed across randomized arms between the pre- and post-VRC01 time points.
Overall Number of Participants Analyzed 37
Median (Inter-Quartile Range)
Unit of Measure: log10 ratio
0.09
(-0.22 to 0.33)
6.Secondary Outcome
Title Cell-associated HIV-1 RNA in Total CD4+ Cells
Hide Description 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.
Time Frame Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of participants with available cell-associated HIV-1 RNA results
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/million CD4
Baseline Number Analyzed 19 participants 19 participants
1.60
(0.90 to 2.09)
1.38
(0.90 to 2.03)
Week 3 Number Analyzed 19 participants 19 participants
1.62
(0.87 to 2.09)
1.56
(0.71 to 1.82)
Week 6 Number Analyzed 18 participants 19 participants
1.48
(1.11 to 2.10)
1.41
(0.99 to 1.90)
Week 9 Number Analyzed 18 participants 19 participants
1.56
(1.14 to 1.90)
1.56
(0.74 to 1.89)
Week 12 Number Analyzed 18 participants 19 participants
1.62
(0.73 to 2.03)
1.51
(0.76 to 2.10)
7.Secondary Outcome
Title Cell-associated HIV-1 DNA in Total CD4+ Cells
Hide Description 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.
Time Frame Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of participants with available cell-associated HIV-1 DNA results
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/million CD4
Baseline Number Analyzed 20 participants 19 participants
3.05
(2.42 to 3.20)
3.00
(2.53 to 3.18)
Week 3 Number Analyzed 20 participants 19 participants
2.99
(2.50 to 3.15)
2.89
(2.61 to 3.00)
Week 6 Number Analyzed 19 participants 19 participants
2.99
(2.46 to 3.07)
2.92
(2.54 to 3.07)
Week 9 Number Analyzed 19 participants 19 participants
2.96
(2.46 to 3.23)
2.91
(2.57 to 3.15)
Week 12 Number Analyzed 19 participants 19 participants
3.01
(2.70 to 3.17)
2.90
(2.55 to 3.12)
8.Secondary Outcome
Title Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells
Hide Description 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.
Time Frame Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of participants with available cell-associated HIV-1 RNA/DNA ratio
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: log10 ratio
Baseline Number Analyzed 19 participants 19 participants
-1.35
(-1.63 to -1.02)
-1.51
(-1.69 to -1.30)
Week 3 Number Analyzed 19 participants 19 participants
-1.29
(-1.84 to -0.74)
-1.38
(-1.57 to -1.11)
Week 6 Number Analyzed 18 participants 19 participants
-1.28
(-1.54 to -0.88)
-1.44
(-1.78 to -1.19)
Week 9 Number Analyzed 18 participants 19 participants
-1.37
(-1.55 to -1.06)
-1.40
(-1.80 to -1.02)
Week 12 Number Analyzed 18 participants 19 participants
-1.42
(-1.80 to -1.04)
-1.33
(-1.87 to -1.09)
9.Secondary Outcome
Title Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit
Hide Description

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.

Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of participants with available SCA results
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
Screening Number Analyzed 20 participants 20 participants
13
  65.0%
12
  60.0%
Entry Number Analyzed 20 participants 20 participants
8
  40.0%
10
  50.0%
Week 1 Number Analyzed 20 participants 0 participants
9
  45.0%
Week 3 Number Analyzed 20 participants 20 participants
9
  45.0%
11
  55.0%
Week 4 Number Analyzed 19 participants 0 participants
11
  57.9%
Week 6 Number Analyzed 19 participants 19 participants
11
  57.9%
12
  63.2%
Week 7 Number Analyzed 0 participants 19 participants
11
  57.9%
Week 9 Number Analyzed 18 participants 19 participants
13
  72.2%
9
  47.4%
Week 10 Number Analyzed 0 participants 19 participants
11
  57.9%
Week 12 Number Analyzed 19 participants 19 participants
11
  57.9%
13
  68.4%
10.Secondary Outcome
Title CD4+ T-cell Counts
Hide Description Baseline measure represents the average of screening and entry results
Time Frame Measured at screening, entry and weeks 6, 12, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of all participants with available CD4+ results
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Baseline Number Analyzed 20 participants 20 participants
701
(594 to 952)
685
(535 to 843)
Week 6 Number Analyzed 19 participants 19 participants
709
(564 to 995)
697
(532 to 807)
Week 12 Number Analyzed 19 participants 18 participants
734
(616 to 886)
671
(513 to 873)
Week 18 Number Analyzed 19 participants 19 participants
709
(529 to 885)
672
(475 to 844)
Week 30 Number Analyzed 18 participants 19 participants
750
(612 to 1025)
712
(486 to 806)
11.Secondary Outcome
Title CD8+ T-cell Counts
Hide Description Baseline measure represents the average of screening and entry results
Time Frame Measured at screening, entry and weeks 6, 12, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of all participants with available CD8+ results
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Baseline Number Analyzed 20 participants 20 participants
801
(490 to 1210)
617
(480 to 744)
Week 6 Number Analyzed 19 participants 19 participants
688
(469 to 977)
614
(481 to 825)
Week 12 Number Analyzed 19 participants 18 participants
649
(508 to 1039)
620
(439 to 852)
Week 18 Number Analyzed 19 participants 19 participants
766
(495 to 1214)
665
(421 to 766)
Week 30 Number Analyzed 18 participants 19 participants
731
(551 to 990)
655
(436 to 740)
12.Secondary Outcome
Title Total/Inducible Virus Recovery - Stimulated HIV-1 RNA
Hide Description As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated
Time Frame Measured at pre-entry, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
Pre-entry
2.83
(1.81 to 3.16)
2.85
(2.28 to 3.49)
Week 6
2.74
(2.31 to 3.41)
3.12
(2.11 to 3.54)
Week 12
2.74
(2.53 to 3.18)
2.63
(2.27 to 3.47)
13.Secondary Outcome
Title Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA
Hide Description As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated
Time Frame Measured at pre-entry, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
Pre-entry Number Analyzed 19 participants 19 participants
1.00
(0.50 to 1.86)
1.00
(0.00 to 1.81)
Week 6 Number Analyzed 19 participants 19 participants
1.44
(0.71 to 1.95)
0.92
(0.00 to 1.61)
Week 12 Number Analyzed 18 participants 19 participants
1.25
(0.50 to 1.90)
1.53
(1.00 to 2.01)
14.Secondary Outcome
Title Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio
Hide Description 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.
Time Frame Measured at pre-entry, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: ratio
Pre-entry Number Analyzed 19 participants 19 participants
16.73
(4.76 to 104.29)
25.49
(8.12 to 115.48)
Week 6 Number Analyzed 19 participants 19 participants
21.03
(5.58 to 78.37)
40.50
(10.77 to 759.42)
Week 12 Number Analyzed 18 participants 19 participants
34.12
(5.57 to 93.90)
16.09
(9.00 to 43.11)
15.Secondary Outcome
Title Total/Inducible Virus Recovery - Stimulated Cell Fluor
Hide Description As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated.
Time Frame Measured at pre-entry, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available stimulated cell fluor results from virus recovery assay
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: million light units
Pre-entry
25.86
(22.14 to 30.42)
26.05
(21.42 to 30.09)
Week 6
24.68
(22.00 to 30.09)
26.13
(21.79 to 29.81)
Week 12
27.38
(22.12 to 31.25)
26.97
(22.57 to 32.01)
16.Secondary Outcome
Title Total/Inducible Virus Recovery - Unstimulated Cell Fluor
Hide Description As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated.
Time Frame Measured at pre-entry, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available unstimulated cell fluor results from virus recovery assay
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: million light units
Pre-entry Number Analyzed 19 participants 19 participants
6.86
(5.70 to 13.34)
5.87
(4.57 to 6.93)
Week 6 Number Analyzed 19 participants 19 participants
6.39
(4.94 to 8.01)
6.22
(5.00 to 8.76)
Week 12 Number Analyzed 18 participants 19 participants
8.53
(6.20 to 12.16)
6.27
(5.05 to 8.38)
17.Secondary Outcome
Title Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio
Hide Description 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.
Time Frame Measured at pre-entry, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: ratio
Pre-entry Number Analyzed 19 participants 19 participants
2.91
(2.14 to 4.65)
4.32
(3.60 to 5.13)
Week 6 Number Analyzed 19 participants 19 participants
4.20
(3.04 to 4.78)
3.87
(3.36 to 5.49)
Week 12 Number Analyzed 18 participants 19 participants
3.33
(2.16 to 4.62)
3.76
(3.52 to 4.38)
18.Secondary Outcome
Title Total/Inducible Virus Recovery - Percentage of Total CD4 Yield
Hide Description As part of the total virus recovery assay, results for %tCD4 yield are generated.
Time Frame Measured at pre-entry, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available %tCD4 yield results from virus recovery assay
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: percentage of Total CD4 Yield
Pre-entry
25.35
(20.00 to 32.17)
22.00
(19.00 to 27.00)
Week 6
25.00
(18.00 to 32.14)
22.38
(17.65 to 33.33)
Week 12
25.00
(21.00 to 30.32)
22.58
(18.81 to 29.00)
19.Secondary Outcome
Title Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA
Hide Description 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)
Time Frame Measured at pre-entry, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: fold change
0.74
(0.31 to 8.38)
1.32
(0.30 to 1.99)
20.Secondary Outcome
Title Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA
Hide Description 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)
Time Frame Measured at pre-entry, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: fold change
1.37
(1.00 to 2.11)
1.00
(0.19 to 2.42)
21.Secondary Outcome
Title Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio
Hide Description 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)
Time Frame Measured at pre-entry and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: fold change
0.69
(0.20 to 3.71)
0.85
(0.21 to 12.38)
22.Secondary Outcome
Title Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor
Hide Description 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)
Time Frame Measured at pre-entry, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available stimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: fold change
0.97
(0.91 to 1.09)
0.97
(0.92 to 1.05)
23.Secondary Outcome
Title Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor
Hide Description 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)
Time Frame Measured at pre-entry, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: fold change
0.93
(0.66 to 1.15)
1.12
(1.02 to 1.39)
24.Secondary Outcome
Title Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio
Hide Description 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)
Time Frame Measured at pre-entry, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: fold change
1.08
(0.84 to 1.64)
0.85
(0.73 to 1.08)
25.Secondary Outcome
Title Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield
Hide Description 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)
Time Frame Measured at pre-entry, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants with available %tCD4 yield results from virus recovery assay at pre-entry and week 6 time points
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: fold change
1.00
(0.81 to 1.41)
1.06
(0.77 to 1.27)
26.Secondary Outcome
Title VRC01 Antibody Level
Hide Description

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.

Time Frame Measured at entry and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of all participants with available results.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) 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

Participants received an infusion of placebo (normal saline) 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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: ug/mL
Week 0 - Pre-Infusion Number Analyzed 20 participants 20 participants
0.1
(0.1 to 0.1)
0.1
(0.1 to 0.1)
Week 0 - Post-Infusion Number Analyzed 20 participants 0 participants
1726.2
(1492.5 to 1950.3)
Week 1 Number Analyzed 20 participants 20 participants
259.9
(213.0 to 297.5)
0.1
(0.1 to 0.1)
Week 2 Number Analyzed 20 participants 18 participants
147.4
(123.3 to 182.1)
0.1
(0.1 to 0.1)
Week 3 - Pre-Infusion Number Analyzed 20 participants 20 participants
113.6
(102.2 to 130.0)
0.1
(0.1 to 0.1)
Week 3 - Post-Infusion Number Analyzed 19 participants 0 participants
1807.7
(1617.0 to 2105.5)
Week 4 Number Analyzed 19 participants 19 participants
361.9
(295.4 to 432.3)
0.1
(0.1 to 0.1)
Week 5 Number Analyzed 20 participants 19 participants
216.9
(174.6 to 254.2)
0.1
(0.1 to 0.1)
Week 6 - Pre-Infusion Number Analyzed 19 participants 19 participants
135.8
(112.2 to 164.5)
0.1
(0.1 to 0.1)
Week 6 - Post-Infusion Number Analyzed 0 participants 18 participants
1643.5
(1483.3 to 2041.5)
Week 7 Number Analyzed 18 participants 19 participants
95.9
(63.4 to 119.2)
277.7
(240.7 to 318.2)
Week 8 Number Analyzed 17 participants 18 participants
56.2
(35.5 to 82.7)
158.0
(126.6 to 193.5)
Week 9 - Pre-Infusion Number Analyzed 19 participants 19 participants
42.1
(21.1 to 56.8)
98.7
(82.8 to 167.1)
Week 9 - Post-Infusion Number Analyzed 0 participants 18 participants
1717.8
(1446.9 to 2153.0)
Week 10 Number Analyzed 17 participants 19 participants
37.8
(27.6 to 47.4)
373.8
(302.3 to 416.0)
Week 11 Number Analyzed 17 participants 19 participants
19.3
(10.4 to 28.1)
217.2
(178.0 to 301.2)
Week 12 Number Analyzed 19 participants 19 participants
13.4
(6.3 to 25.1)
131.1
(106.3 to 215.3)
Week 15 Number Analyzed 19 participants 19 participants
5.0
(1.9 to 10.9)
42.1
(30.6 to 66.6)
Week 18 Number Analyzed 19 participants 19 participants
2.1
(0.1 to 5.2)
18.3
(9.0 to 45.6)
Week 30 Number Analyzed 15 participants 19 participants
0.1
(0.1 to 0.1)
0.1
(0.1 to 0.1)
27.Secondary Outcome
Title Detectability of Antibody to VRC01 as Measured in Serum
Hide Description 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.
Time Frame Measured at week 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) 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

Participants received an infusion of placebo (normal saline) 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 Number of Participants Analyzed 19 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
28.Secondary Outcome
Title Levels of T-cell Activation
Hide Description

% 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.

Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed. See outcome measure description for reasoning.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) 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

Participants received an infusion of placebo (normal saline) 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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Secondary Outcome
Title Levels of NK Cell Activation
Hide Description

% 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.

Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed. See outcome measure description for reasoning.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Plasma Levels of sCD163
Hide Description 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.
Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed. See outcome measure description for reasoning.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
31.Secondary Outcome
Title Plasma Levels of sCD14
Hide Description 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.
Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed. See outcome measure description for reasoning.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
32.Secondary Outcome
Title Plasma Levels of Interleukin-6 (IL-6)
Hide Description 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.
Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed. See outcome measure description for reasoning.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
33.Secondary Outcome
Title Plasma Levels of Human Soluble Tumor Necrosis Factor Alpha-receptor (sTNFαR)
Hide Description 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.
Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed. See outcome measure description for reasoning.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
34.Secondary Outcome
Title Plasma Levels of Tumor Necrosis Factor Alpha (TNFα)
Hide Description 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.
Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed. See outcome measure description for reasoning.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
35.Secondary Outcome
Title Plasma Levels of High-sensitivity C-reactive Protein (hsCRP)
Hide Description 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.
Time Frame Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis not performed. See outcome measure description for reasoning.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
36.Secondary Outcome
Title VRC01 Antibody Level Relative to Infusion Timing
Hide Description 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
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of all participants with available results.
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description:

Participants received an infusion of VRC01 at Day 0 and Week 3 and an infusion of placebo (normal saline) 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

Participants received an infusion of placebo (normal saline) 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 Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: ug/mL
First dose - Post-Infusion Number Analyzed 20 participants 18 participants
1726.2
(1492.5 to 1950.3)
1643.5
(1483.3 to 2041.5)
One week after first infusion Number Analyzed 20 participants 19 participants
259.9
(213.0 to 297.5)
277.7
(240.7 to 318.2)
Two weeks after first infusion Number Analyzed 20 participants 18 participants
147.4
(123.3 to 182.1)
158.0
(126.6 to 193.5)
Three weeks after first infusion Number Analyzed 20 participants 19 participants
113.6
(102.2 to 130.0)
98.7
(82.8 to 167.1)
Second dose - Post-infusion Number Analyzed 19 participants 18 participants
1807.7
(1617.0 to 2105.5)
1717.8
(1446.9 to 2153.0)
One week after second infusion Number Analyzed 19 participants 19 participants
361.9
(295.4 to 432.3)
373.8
(302.3 to 416.0)
Two weeks after second infusion Number Analyzed 20 participants 19 participants
216.9
(174.6 to 254.2)
217.2
(178.0 to 301.2)
Three weeks after second infusion Number Analyzed 19 participants 19 participants
135.8
(112.2 to 164.5)
131.1
(106.3 to 215.3)
Six weeks after second infusion Number Analyzed 19 participants 19 participants
42.1
(21.1 to 56.8)
42.1
(30.6 to 66.6)
Nine weeks after second infusion Number Analyzed 19 participants 19 participants
13.4
(6.3 to 25.1)
18.3
(9.0 to 45.6)
Time Frame From first infusion through end of study follow up (the duration of the study is 30 weeks)
Adverse Event Reporting Description 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
 
Arm/Group Title Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   1/20 (5.00%) 
Nervous system disorders     
Syncope  1  0/20 (0.00%)  1/20 (5.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: VRC01 Followed by Placebo Arm B: Placebo Followed by VRC01
Affected / at Risk (%) Affected / at Risk (%)
Total   16/20 (80.00%)   17/20 (85.00%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/20 (0.00%)  1/20 (5.00%) 
Eye disorders     
Eye movement disorder  1  0/20 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/20 (0.00%)  1/20 (5.00%) 
Anogenital dysplasia  1  1/20 (5.00%)  0/20 (0.00%) 
Nausea  1  1/20 (5.00%)  3/20 (15.00%) 
Reactive gastropathy  1  0/20 (0.00%)  1/20 (5.00%) 
General disorders     
Chest discomfort  1  0/20 (0.00%)  1/20 (5.00%) 
Chest pain  1  0/20 (0.00%)  1/20 (5.00%) 
Chills  1  1/20 (5.00%)  2/20 (10.00%) 
Fatigue  1  1/20 (5.00%)  2/20 (10.00%) 
Influenza like illness  1  1/20 (5.00%)  0/20 (0.00%) 
Malaise  1  0/20 (0.00%)  1/20 (5.00%) 
Pain  1  1/20 (5.00%)  0/20 (0.00%) 
Pyrexia  1  0/20 (0.00%)  2/20 (10.00%) 
Infections and infestations     
Acute sinusitis  1  0/20 (0.00%)  1/20 (5.00%) 
Influenza  1  0/20 (0.00%)  1/20 (5.00%) 
Oral herpes  1  1/20 (5.00%)  0/20 (0.00%) 
Upper respiratory tract infection  1  0/20 (0.00%)  2/20 (10.00%) 
Investigations     
Alanine aminotransferase  1  2/20 (10.00%)  0/20 (0.00%) 
Aspartate aminotransferase  1  1/20 (5.00%)  1/20 (5.00%) 
Bilirubin conjugated abnormal  1  2/20 (10.00%)  0/20 (0.00%) 
Bilirubin conjugated increased  1  1/20 (5.00%)  1/20 (5.00%) 
Blood alkaline phosphatase abnormal  1  1/20 (5.00%)  0/20 (0.00%) 
Blood bilirubin abnormal  1  1/20 (5.00%)  1/20 (5.00%) 
Blood bilirubin increased  1  2/20 (10.00%)  2/20 (10.00%) 
Blood creatinine abnormal  1  2/20 (10.00%)  3/20 (15.00%) 
Blood creatinine increased  1  1/20 (5.00%)  3/20 (15.00%) 
Blood glucose increased  1  1/20 (5.00%)  0/20 (0.00%) 
Blood potassium decreased  1  1/20 (5.00%)  1/20 (5.00%) 
Blood potassium increased  1  0/20 (0.00%)  1/20 (5.00%) 
Blood sodium decreased  1  0/20 (0.00%)  1/20 (5.00%) 
Creatinine renal clearance decreased  1  6/20 (30.00%)  10/20 (50.00%) 
Haemoglobin decreased  1  1/20 (5.00%)  0/20 (0.00%) 
Neutrophil count decreased  1  0/20 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/20 (5.00%)  2/20 (10.00%) 
Back pain  1  1/20 (5.00%)  1/20 (5.00%) 
Flank pain  1  0/20 (0.00%)  1/20 (5.00%) 
Muscle spasms  1  1/20 (5.00%)  0/20 (0.00%) 
Muscle twitching  1  0/20 (0.00%)  1/20 (5.00%) 
Myalgia  1  0/20 (0.00%)  2/20 (10.00%) 
Pain in extremity  1  2/20 (10.00%)  1/20 (5.00%) 
Nervous system disorders     
Burning sensation  1  0/20 (0.00%)  1/20 (5.00%) 
Dizziness  1  0/20 (0.00%)  2/20 (10.00%) 
Headache  1  1/20 (5.00%)  2/20 (10.00%) 
Hypoaesthesia  1  0/20 (0.00%)  2/20 (10.00%) 
Lethargy  1  0/20 (0.00%)  1/20 (5.00%) 
Paraesthesia  1  0/20 (0.00%)  1/20 (5.00%) 
Tremor  1  0/20 (0.00%)  1/20 (5.00%) 
Unresponsive to stimuli  1  0/20 (0.00%)  1/20 (5.00%) 
Psychiatric disorders     
Anxiety  1  0/20 (0.00%)  1/20 (5.00%) 
Insomnia  1  0/20 (0.00%)  1/20 (5.00%) 
Psychogenic seizure  1  0/20 (0.00%)  1/20 (5.00%) 
Reproductive system and breast disorders     
Genital lesion  1  1/20 (5.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/20 (5.00%)  4/20 (20.00%) 
Dyspnoea  1  0/20 (0.00%)  1/20 (5.00%) 
Dyspnoea exertional  1  0/20 (0.00%)  1/20 (5.00%) 
Nasal congestion  1  0/20 (0.00%)  2/20 (10.00%) 
Oropharyngeal pain  1  0/20 (0.00%)  1/20 (5.00%) 
Pulmonary sarcoidosis  1  0/20 (0.00%)  1/20 (5.00%) 
Rhinorrhoea  1  0/20 (0.00%)  2/20 (10.00%) 
Sinus congestion  1  3/20 (15.00%)  1/20 (5.00%) 
Sinus pain  1  1/20 (5.00%)  0/20 (0.00%) 
Sneezing  1  0/20 (0.00%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders     
Fixed drug eruption  1  1/20 (5.00%)  0/20 (0.00%) 
Night sweats  1  0/20 (0.00%)  1/20 (5.00%) 
Pruritus generalised  1  1/20 (5.00%)  0/20 (0.00%) 
Rash  1  2/20 (10.00%)  0/20 (0.00%) 
Rash papular  1  1/20 (5.00%)  0/20 (0.00%) 
Vascular disorders     
Hot flush  1  0/20 (0.00%)  1/20 (5.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
EMail: ACTGCT.Gov@s-3.com
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02411539    
Other Study ID Numbers: ACTG A5342
12003 ( Registry Identifier: DAIDS-ES )
UM1AI068636 ( U.S. NIH Grant/Contract )
First Submitted: April 2, 2015
First Posted: April 8, 2015
Results First Submitted: March 17, 2017
Results First Posted: July 31, 2017
Last Update Posted: July 10, 2018