A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117 Monoclonal Antibody in HIV-infected and HIV-uninfected Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Rockefeller University
- Enrollment
- 49
- Locations
- 4
- Primary Endpoint
- Safety and tolerability
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The proposed study is a first-in-man phase I study that aims to evaluate the safety, tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and its antiretroviral activity in HIV-infected subjects.
Detailed Description
In preclinical studies carried out in humanized mice and non-human primates, 3BNC117 alone or in combination with other neutralizing antibodies led to protection from HIV-1 or SHIV infection and also to sustained suppression of HIV-1 plasma viremia. The aims of this protocol are to evaluate the safety, tolerability and pharmacokinetics profile of 3BNC117 in both HIV-infected and HIV-uninfected subjects,and its antiretroviral activity in HIV-infected subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Group 1 (HIV-uninfected):
- •Adult males and females, age 18 to 65
- •Amenable to HIV risk reduction counseling and agrees to maintaining behavior consistent with low risk of HIV exposure;
- •If a sexually active male or female, participating in sexual activity that could lead to pregnancy, agrees to use an effective method of contraception throughout the study.
- •Groups 2-5 (HIV-infected):
- •Age 18 to 65
- •HIV infection confirmed by ELISA and immunoblot
- •Groups 2A-D - on ART with HIV-1 plasma RNA levels below 100,000 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA level between 2,000-100,000 copies/ml by standard assays on 2 occasions at least 1 week apart;
- •Group 2E - Untreated HIV-infected (not on ART for at least 8 weeks): HIV-1 RNA plasma levels between 2,000 - 100,000 copies/ml;
- •Group 3 - Untreated HIV controllers (not on ART for at least 8 weeks): HIV-1 RNA plasma level of \< 2,000 copies/ml by standard assays, on 2 occasions, at least 1 week apart, and ART-naive.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety and tolerability
Time Frame: 24 weeks
To evaluate the safety and tolerability profile of one or two intravenous infusions of 3BNC117 at 3 increasing dose levels in HIV-infected and HIV-uninfected individuals.
Secondary Outcomes
- Pharmacokinetic profile(24 hours post infusion)