Trial Outcomes & Findings for 3BNC117 Monoclonal Antibody in HIV-infected Subjects During Treatment Interruption (NCT NCT02446847)
NCT ID: NCT02446847
Last Updated: 2020-07-23
Results Overview
Virologic rebound is defined as confirmed plasma HIV-1 RNA level \> 200 copies/ml in two separate occasions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
8 weeks
Results posted on
2020-07-23
Participant Flow
Participant milestones
| Measure |
Group A: 3BNC117 IV + ART Interruption
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.
|
Group B: 3BNC117 IV + ART Interruption
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 Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3BNC117 Monoclonal Antibody in HIV-infected Subjects During Treatment Interruption
Baseline characteristics by cohort
| Measure |
Group A: 3BNC117 IV + ART Interruption
n=8 Participants
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.
|
Group B: 3BNC117 IV + ART Interruption
n=8 Participants
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
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
38 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksVirologic rebound is defined as confirmed plasma HIV-1 RNA level \> 200 copies/ml in two separate occasions
Outcome measures
| Measure |
Group A: 3BNC117 IV + ART Interruption
n=6 Participants
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.
|
Group B: 3BNC117 IV + ART Interruption
n=8 Participants
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.
|
|---|---|---|
|
Number of Participants With Virologic Rebound at 8 Weeks After Interruption of Antiretroviral Therapy
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 36 weeksThe percentage of participants who experienced adverse events (e.g. signs, symptoms and laboratory abnormalities) following 3BNC117 infusions.
Outcome measures
| Measure |
Group A: 3BNC117 IV + ART Interruption
n=8 Participants
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.
|
Group B: 3BNC117 IV + ART Interruption
n=8 Participants
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.
|
|---|---|---|
|
The Rate of Signs, Symptoms and Laboratory Abnormalities After 3BNC117 Infusions
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Two participants excluded from analysis because of detectable plasma HIV-1 RNA levels prior to first administration of the investigational product.
The plasma concentrations of 3BNC117 at the time of viral rebound (i.e. confirmed plasma HIV-1 RNA levels \> 200 copies/ml).
Outcome measures
| Measure |
Group A: 3BNC117 IV + ART Interruption
n=6 Participants
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.
|
Group B: 3BNC117 IV + ART Interruption
n=7 Participants
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.
|
|---|---|---|
|
The Plasma Level of 3BNC117 at the Time of Viral Rebound.
|
61.15 micrograms/ml
Standard Deviation 42.41
|
74.37 micrograms/ml
Standard Deviation 65.17
|
Adverse Events
Group A: 3BNC117 IV + ART Interruption
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group B: 3BNC117 IV + ART Interruption
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: 3BNC117 IV + ART Interruption
n=8 participants at risk
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.
|
Group B: 3BNC117 IV + ART Interruption
n=8 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/8 • Participants were followed for 36 weeks from enrollment.
|
12.5%
1/8 • Participants were followed for 36 weeks from enrollment.
|
Other adverse events
| Measure |
Group A: 3BNC117 IV + ART Interruption
n=8 participants at risk
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.
|
Group B: 3BNC117 IV + ART Interruption
n=8 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Headache
|
75.0%
6/8 • Number of events 7 • Participants were followed for 36 weeks from enrollment.
|
25.0%
2/8 • Number of events 2 • Participants were followed for 36 weeks from enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
62.5%
5/8 • Number of events 5 • Participants were followed for 36 weeks from enrollment.
|
75.0%
6/8 • Number of events 7 • Participants were followed for 36 weeks from enrollment.
|
|
Nervous system disorders
Paresthesia upper extremity
|
37.5%
3/8 • Number of events 3 • Participants were followed for 36 weeks from enrollment.
|
0.00%
0/8 • Participants were followed for 36 weeks from enrollment.
|
|
Cardiac disorders
Chest tightness
|
25.0%
2/8 • Number of events 2 • Participants were followed for 36 weeks from enrollment.
|
0.00%
0/8 • Participants were followed for 36 weeks from enrollment.
|
|
General disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Participants were followed for 36 weeks from enrollment.
|
12.5%
1/8 • Number of events 1 • Participants were followed for 36 weeks from enrollment.
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 1 • Participants were followed for 36 weeks from enrollment.
|
12.5%
1/8 • Number of events 1 • Participants were followed for 36 weeks from enrollment.
|
|
Gastrointestinal disorders
Hyperbilirubinemia
|
12.5%
1/8 • Number of events 1 • Participants were followed for 36 weeks from enrollment.
|
12.5%
1/8 • Number of events 1 • Participants were followed for 36 weeks from enrollment.
|
Additional Information
Dr. Marina Caskey, Associate Professor of Clinical Investigation
The Rockefeller University
Phone: 212-327-7396
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place