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3BNC117 Monoclonal Antibody in HIV-infected Subjects During Treatment Interruption

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ClinicalTrials.gov Identifier: NCT02446847
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rockefeller University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: 3BNC117
Other: ART Interruption
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption
Hide Arm/Group Description

Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Period Title: Overall Study
Started 8 8
Completed 8 6
Not Completed 0 2
Arm/Group Title Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption Total
Hide Arm/Group Description

Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
46
(26 to 62)
38
(27 to 59)
42
(26 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
0
   0.0%
1
  12.5%
1
   6.3%
Male
8
 100.0%
7
  87.5%
15
  93.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
2
  25.0%
0
   0.0%
2
  12.5%
Not Hispanic or Latino
6
  75.0%
8
 100.0%
14
  87.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
  12.5%
1
   6.3%
Black or African American
3
  37.5%
5
  62.5%
8
  50.0%
White
5
  62.5%
2
  25.0%
7
  43.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 6
1.Primary Outcome
Title Number of Participants With Virologic Rebound at 8 Weeks After Interruption of Antiretroviral Therapy
Hide Description Virologic rebound is defined as confirmed plasma HIV-1 RNA level > 200 copies/ml in two separate occasions
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption
Hide Arm/Group Description:

Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Overall Number of Participants Analyzed 6 8
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
3
  37.5%
2.Primary Outcome
Title The Rate of Signs, Symptoms and Laboratory Abnormalities After 3BNC117 Infusions
Hide Description The percentage of participants who experienced adverse events (e.g. signs, symptoms and laboratory abnormalities) following 3BNC117 infusions.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption
Hide Arm/Group Description:

Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Overall Number of Participants Analyzed 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
8
 100.0%
3.Secondary Outcome
Title The Plasma Level of 3BNC117 at the Time of Viral Rebound.
Hide Description The plasma concentrations of 3BNC117 at the time of viral rebound (i.e. confirmed plasma HIV-1 RNA levels > 200 copies/ml).
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants excluded from analysis because of detectable plasma HIV-1 RNA levels prior to first administration of the investigational product.
Arm/Group Title Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption
Hide Arm/Group Description:

Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Overall Number of Participants Analyzed 6 7
Mean (Standard Deviation)
Unit of Measure: micrograms/ml
61.15  (42.41) 74.37  (65.17)
Time Frame Participants were followed for 36 weeks from enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption
Hide Arm/Group Description

Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.

3BNC117: 3BNC117 infusions

ART Interruption: Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

All-Cause Mortality
Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/8 (0.00%)    
Hide Serious Adverse Events
Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      1/8 (12.50%)    
Nervous system disorders     
Transient ischemic attack * [1]  0/8 (0.00%)  1/8 (12.50%) 
*
Indicates events were collected by non-systematic assessment
[1]
The participant was admitted to the hospital with a transient ischemic attach 30 wks after last study intervention. The event was considered not related to the study, but secondary to underlying risk factors.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A: 3BNC117 IV + ART Interruption Group B: 3BNC117 IV + ART Interruption
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      6/8 (75.00%)    
Blood and lymphatic system disorders     
Anemia *  1/8 (12.50%)  1 1/8 (12.50%)  1
Cardiac disorders     
Chest tightness *  2/8 (25.00%)  2 0/8 (0.00%)  0
Gastrointestinal disorders     
Hyperbilirubinemia *  1/8 (12.50%)  1 1/8 (12.50%)  1
General disorders     
Back pain *  1/8 (12.50%)  1 1/8 (12.50%)  1
Nervous system disorders     
Headache *  6/8 (75.00%)  7 2/8 (25.00%)  2
Paresthesia upper extremity *  3/8 (37.50%)  3 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Tract Infection *  5/8 (62.50%)  5 6/8 (75.00%)  7
*
Indicates events were collected by non-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: Dr. Marina Caskey, Associate Professor of Clinical Investigation
Organization: The Rockefeller University
Phone: 212-327-7396
EMail: mcaskey@rockefeller.edu
Layout table for additonal information
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT02446847    
Other Study ID Numbers: MCA-0867
First Submitted: March 17, 2015
First Posted: May 18, 2015
Results First Submitted: June 3, 2020
Results First Posted: July 23, 2020
Last Update Posted: July 23, 2020