Trial Outcomes & Findings for A Study of the Safety and Antiretroviral Activity of 3BNC117 (NCT NCT02588586)
NCT ID: NCT02588586
Last Updated: 2021-06-16
Results Overview
Viral 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
17 participants
Primary outcome timeframe
36 weeks
Results posted on
2021-06-16
Participant Flow
No pre-assignment phase
Participant milestones
| Measure |
3BNC117 + ART Interruption
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
3BNC117: 3BNC117 infusions
Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Antiretroviral Activity of 3BNC117
Baseline characteristics by cohort
| Measure |
3BNC117 + ART Interruption
n=17 Participants
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
3BNC117: 3BNC117 infusions
Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
43 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 36 weeksViral rebound is defined as confirmed plasma HIV-1 RNA level \> 200 copies/ml in two separate occasions
Outcome measures
| Measure |
3BNC117 + ART Interruption
n=15 Participants
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
3BNC117: 3BNC117 infusions
Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
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|---|---|
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Rate of Viral Rebound at 12 Weeks After Interruption of Antiretroviral Therapy
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 3BNC117 serum levels
Serum level of 3BNC117 at the time of viral rebound, measured in micrograms per ml
Outcome measures
| Measure |
3BNC117 + ART Interruption
n=14 Participants
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
3BNC117: 3BNC117 infusions
Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
|
|---|---|
|
Serum Level of 3BNC117 at the Time of Viral Rebound, Measured in Micrograms Per ml
|
46.87 mg/ml
Standard Deviation 27.67
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SECONDARY outcome
Timeframe: 36 weeksViral rebound is defined as confirmed plasma HIV-1 RNA level \> 200 copies/ml in two separate occasions
Outcome measures
| Measure |
3BNC117 + ART Interruption
n=15 Participants
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
3BNC117: 3BNC117 infusions
Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
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|---|---|
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Time to Viral Rebound After Interruption of Antiretroviral Therapy
|
5.5 weeks
Interval 2.0 to 17.0
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SECONDARY outcome
Timeframe: 60 weeksNumber of Participants with Adverse Events as a Measure of Safety and Tolerability
Outcome measures
| Measure |
3BNC117 + ART Interruption
n=17 Participants
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
3BNC117: 3BNC117 infusions
Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
|
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
16 Participants
|
Adverse Events
3BNC117 + ART Interruption
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3BNC117 + ART Interruption
n=17 participants at risk
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
3BNC117: 3BNC117 infusions
Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
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|---|---|
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Psychiatric disorders
Acute psychotic episode
|
5.9%
1/17 • Number of events 1 • 60 weeks
|
Other adverse events
| Measure |
3BNC117 + ART Interruption
n=17 participants at risk
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
3BNC117: 3BNC117 infusions
Antiretroviral Treatment Interruption: Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
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|---|---|
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General disorders
Malaise
|
23.5%
4/17 • Number of events 6 • 60 weeks
|
|
Gastrointestinal disorders
Nausea
|
23.5%
4/17 • Number of events 4 • 60 weeks
|
|
General disorders
Headache
|
11.8%
2/17 • Number of events 2 • 60 weeks
|
|
General disorders
Dizziness
|
17.6%
3/17 • Number of events 4 • 60 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
3/17 • Number of events 3 • 60 weeks
|
Additional Information
Dr. Marina Caskey, Professor of Clinical Investigation
The Rockefeller University
Phone: 2123277396
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place