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Trial record 80 of 3104 for:    HIV Infections | NIH

Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection

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: NCT02664415
Recruitment Status : Completed
First Posted : January 27, 2016
Results First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
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 for VRC01
Enrollment 23
Recruitment Details This study was conducted at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. Participants were recruited between 9 August 2016 and 9 January 2017, from ongoing Acute HIV Infection (AHI) cohorts and received ART during AHI via a separately-funded protocol (clinicaltrials.gov NCT00796263).
Pre-assignment Details Twenty-three participants were enrolled, 4 were withdrawn prior to randomization because of the unavailability of study product in-country, and 19 were randomized with 5 assigned to placebo and 14 to VRC01. One VRC01 recipient experienced severe generalized urticaria during the first study infusion and did not complete the study.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Period Title: Overall Study
Started 14 5
Completed 13 5
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title VRC01 Placebo for VRC01 Total
Hide Arm/Group Description

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Total of all reporting groups
Overall Number of Baseline Participants 13 5 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 5 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
5
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 5 participants 18 participants
32
(21 to 50)
25
(23 to 48)
29
(21 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 5 participants 18 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
13
 100.0%
5
 100.0%
18
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 5 participants 18 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
13
 100.0%
5
 100.0%
18
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Thailand Number Analyzed 13 participants 5 participants 18 participants
13
 100.0%
5
 100.0%
18
 100.0%
HIV-subtype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 5 participants 18 participants
CRF01_AE
8
  61.5%
4
  80.0%
12
  66.7%
B
3
  23.1%
1
  20.0%
4
  22.2%
CRF01_AE and B co-infection
1
   7.7%
0
   0.0%
1
   5.6%
CRF01_AE/B/C recombinant
1
   7.7%
0
   0.0%
1
   5.6%
Feibig stage at ART initiation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 5 participants 18 participants
I (RNA+, p24-)
1
   7.7%
0
   0.0%
1
   5.6%
II (p24+, IgM-)
7
  53.8%
3
  60.0%
10
  55.6%
III (IgM+, WB-)
5
  38.5%
2
  40.0%
7
  38.9%
[1]
Measure Description:

Fiebig stage is a laboratory staging system for primary HIV infection (Fiebig et al).

Stage I: HIV present in blood samples, only RNA assay positive (RNA+); Stage II: RNA+ and HIV-1 p24 antigen positive (p24+), antibody EIA non-reactive (IgM-); Stage III: RNA+, HIV-1 antigen and HIV IgM-sensitive EIA reactive (IgM+), but Western blot without HIV-a-specific band (WB-) .

The higher stage refers to the later stage of infection.

1.Primary Outcome
Title Number of Participants With Serious Adverse Event
Hide Description Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo
Time Frame Measured up to 10 weeks after last infusion of VRC01 or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized to receive VRC01 or placebo.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 14 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Sustained Virologic Suppression
Time Frame Measured through 24 weeks after ATI
Hide Outcome Measure Data
Hide Analysis Population Description
This is the number of participants who received at least one full dose of VRC01 or placbo, underwent Analytic Treatment Interruption (ATI).
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
   7.7%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments This is to confirm that the p-value from Fisher's Exact test was 1.000.
3.Secondary Outcome
Title Time to Viral Rebound After Cessation of ART
Hide Description

This is the days from Analytic Treatment Interruption (ATI) to:

  1. HIV RNA >= 20 copies/mL.
  2. HIV RNA >= 1000 copies/mL
Time Frame Measured from Baseline ATI through ART resumption.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Median (Full Range)
Unit of Measure: days
Time from ATI to HIV-1 RNA >= 20 copies/mL
29
(9 to 296)
14
(14 to 29)
Time from ATI to HIV-1 RNA >= 1000 copies/mL
33
(13 to 305)
14
(14 to 32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments A comparison of time from ATI to HIV-1 RNA >= 20 copies/mL between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments A comparison of time from ATI to HIV-1 RNA >= 1000 copies/mL between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Level of Rebound Viremia After Cessation of ART
Hide Description This is the HIV-1 RNA levels (copies/mL) at first detection and ART resumption.
Time Frame Measured from Baseline ATI through ART resumption.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Median (Full Range)
Unit of Measure: copies/mL
HIV-1 RNA at first detection
105
(21 to 900)
1015
(229 to 7395)
HIV-1 RNA at ART resumption
3440
(1587 to 31807)
3845
(1401 to 26865)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments This is a p-value, comparing HIV-1 RNA levels at first detection between arms.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments This is p-value, comparing HIV-1 RNA levels at ART resumption between arms.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Time to ART Resumption for Any Reason After Cessation of ART
Hide Description This is the days from ATI to ART resumptions.
Time Frame Measured from Baseline ATI through ART resumption.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one full dose of VRC01 or placebo and underwent ATI.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Median (Full Range)
Unit of Measure: days
35
(14 to 309)
23
(16 to 35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Detectable HIV-1 RNA Via Single Copy Assay
Time Frame Measured from Baseline ATI through ART resumption.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Measure Type: Count of Participants
Unit of Measure: Participants
8
  61.5%
3
  60.0%
7.Secondary Outcome
Title Change in CD4+ T Cell Count From ATI to ART Resumption
Hide Description This is change in CD4+ T cell count from ATI to ART resumption.
Time Frame Measured from Baseline ATI through ART resumption
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Median (Full Range)
Unit of Measure: cells/mm^3
-37
(-258 to 101)
-21
(-248 to 258)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.693
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Total HIV DNA in the Peripheral Compartment
Hide Description This is total HIV DNA levels at baseline ATI, ART resumption and 6 month after ART resumption
Time Frame Measured from ATI through 6 months after ART resumption
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Median (Full Range)
Unit of Measure: copies/10^6 CD4 T cells
Total HIV DNA at baseline ATI
16
(0 to 75)
3
(0 to 54)
Total HIV DNA at ART resumption
24
(3 to 265)
39
(5 to 169)
Total HIV DNA at 6 months after ART resumption
9
(0 to 56)
15
(0 to 60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VRC01
Comments A comparison of total HIV DNA at baseline ATI and ART resumption within the VRC01 arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments The p-value is not adjusted for multiple comparisons.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for VRC01
Comments A comparison of total HIV DNA at baseline ATI and ART resumption within the placebo arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments The p-value is not adjusted for multiple comparisons.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VRC01
Comments A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the VRC01 arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The p-value is adjusted for multiple comparisons.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo for VRC01
Comments A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the placebo arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments The p-value is adjusted for multiple comparisons.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection VRC01
Comments A comparison of total HIV DNA atbaseline ATI and 6 months after ART resumption within the VRC01 arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo for VRC01
Comments A comparison of total HIV DNA at baeline ATI versus 6 months after ART resumption in the placebo arm
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Hospitalized.
Hide Description Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo
Time Frame Measured up to 10 weeks after the last infusion of VRC01 or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who have been randomized to receive VRC01 or Placebo.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 14 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Acute Retroviral Syndrome (ARS)
Hide Description This is the number of participants who have developed during ATI.
Time Frame Measured from Baseline ATI through ART resumption.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one full dose of VRC01 or Placebo and underwent treatment interruption.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Neuropsychological Battery Performance
Hide Description This is a NPZ-4 score,a 4-test NP battery evaluated fine motor function/manual dexterity [Grooved Pegboard test (GP), non-dominant hand], psychomotor speed [Color Trails 1 (CT1), Trail Making A (TM)], and executive function/set shifting [Color Trails 2 (CT2)]. Individual test raw scores were converted to z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance and lower cognitive impairment.
Time Frame Measured from Baseline ATI through ART resumption.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one full dose of VRC01 or Placebo and underwent ATI.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Median (Full Range)
Unit of Measure: Z-score
NPZ-4 at baseline ATI
0.87
(0.26 to 1.48)
1.19
(0.16 to 1.30)
NPZ- at ART resumption
1.25
(0.02 to 1.70)
1.04
(0.41 to 1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments Comparison between arms at baseline ATI
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments Comparison between arms at ART resumption
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VRC01
Comments Comparison between Baseline and ART resumption within VRC01 arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo for VRC01
Comments Comparison between Baseline and ART resumption within Placebo arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
12.Secondary Outcome
Title Computed Score on the Control and Attention Task (i.e., Flanker Task)
Hide Description The Flanker is a measure of executive function, specifically tapping inhibitory control and attention.The scores range from 0 to 10. A higher scores indicate higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli.
Time Frame Measured from Baseline ATI through ART resumption.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description:

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

Overall Number of Participants Analyzed 13 5
Median (Full Range)
Unit of Measure: score
Baseline ATI
8.24
(7.43 to 9.23)
8.36
(8.05 to 8.83)
ART resumption
8.4
(7.3 to 9.7)
8.41
(7.46 to 9.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments Comparison between groups at baseline ATI.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.522
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VRC01, Placebo for VRC01
Comments A comparison between groups at ART resumption.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VRC01
Comments A comparison between baseline ATI and ART resumption within VRC01 group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo for VRC01
Comments A comparison between baseline ATI and ART resumption within Placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Time Frame Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VRC01 Placebo for VRC01
Hide Arm/Group Description

Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

VRC01: 40 mg/kg; administered IV

Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.

Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV

All-Cause Mortality
VRC01 Placebo for VRC01
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
VRC01 Placebo for VRC01
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VRC01 Placebo for VRC01
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/14 (100.00%)      5/5 (100.00%)    
Cardiac disorders     
Hypertension   1/14 (7.14%)  1 0/5 (0.00%)  0
Eye disorders     
Subconjunctival hematoma   1/14 (7.14%)  1 0/5 (0.00%)  0
Gastrointestinal disorders     
Nausea   5/14 (35.71%)  7 1/5 (20.00%)  1
Diarrhea   2/14 (14.29%)  3 1/5 (20.00%)  1
Abdominal gas   0/14 (0.00%)  0 1/5 (20.00%)  1
Aphthous mouth ulcer   1/14 (7.14%)  1 0/5 (0.00%)  0
Loose stool   2/14 (14.29%)  2 0/5 (0.00%)  0
Mouth sore   0/14 (0.00%)  0 1/5 (20.00%)  1
Oral ulcer   1/14 (7.14%)  1 0/5 (0.00%)  0
Pharyngitis   2/14 (14.29%)  3 0/5 (0.00%)  0
Vomiting   1/14 (7.14%)  2 0/5 (0.00%)  0
Sore throat   1/14 (7.14%)  1 1/5 (20.00%)  1
General disorders     
Fatigue   7/14 (50.00%)  8 3/5 (60.00%)  4
Generalized urticaria   1/14 (7.14%)  1 0/5 (0.00%)  0
Chills   1/14 (7.14%)  1 0/5 (0.00%)  0
Hepatobiliary disorders     
ALT increased   1/14 (7.14%)  1 0/5 (0.00%)  0
Immune system disorders     
Allergy   1/14 (7.14%)  1 0/5 (0.00%)  0
Lymphadenopathy, right cervical   1/14 (7.14%)  1 0/5 (0.00%)  0
Infections and infestations     
Chlamydia   0/14 (0.00%)  0 1/5 (20.00%)  1
Common cold   1/14 (7.14%)  1 1/5 (20.00%)  1
Syphilis   2/14 (14.29%)  2 0/5 (0.00%)  0
Upper respiratory tract infection   2/14 (14.29%)  4 1/5 (20.00%)  1
Injury, poisoning and procedural complications     
Infusion site pain   3/14 (21.43%)  3 2/5 (40.00%)  2
Infusion site bruising   2/14 (14.29%)  2 0/5 (0.00%)  0
Infusion site erythema   1/14 (7.14%)  1 0/5 (0.00%)  0
Hematoma   1/14 (7.14%)  1 1/5 (20.00%)  1
Metabolism and nutrition disorders     
Hyperlipidemia   2/14 (14.29%)  2 1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders     
Myalgia   4/14 (28.57%)  4 0/5 (0.00%)  0
Arthralgia   1/14 (7.14%)  1 0/5 (0.00%)  0
Back pain   1/14 (7.14%)  1 0/5 (0.00%)  0
Joint pain   1/14 (7.14%)  1 0/5 (0.00%)  0
Pain in extremity   1/14 (7.14%)  1 0/5 (0.00%)  0
Nervous system disorders     
Headche   4/14 (28.57%)  9 4/5 (80.00%)  8
Confusion   0/14 (0.00%)  0 1/5 (20.00%)  1
Peripheral neuropathy   0/14 (0.00%)  0 1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   2/14 (14.29%)  2 1/5 (20.00%)  1
Skin and subcutaneous tissue disorders     
Acne   2/14 (14.29%)  2 0/5 (0.00%)  0
Allergic dermatitis   1/14 (7.14%)  1 0/5 (0.00%)  0
Dermatitis of dorsum, both hands   1/14 (7.14%)  1 0/5 (0.00%)  0
Eczema   1/14 (7.14%)  1 0/5 (0.00%)  0
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
Name/Title: Biostatistician
Organization: MHRP
Phone: 3015003715
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02664415     History of Changes
Other Study ID Numbers: RV 397
12001 ( Registry Identifier: DAIDS-ES Registry Number )
First Submitted: January 20, 2016
First Posted: January 27, 2016
Results First Submitted: August 3, 2018
Results First Posted: October 17, 2018
Last Update Posted: October 17, 2018