This study evaluates the effects of two infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART and its safety during a brief analytical interruption of antiretroviral therapy.
The proposed study is a Phase II, open label study to evaluate the safety and antiretroviral activity of two and four infusions of 3BNC117 in HIV-infected subjects on combination ART during a brief analytical treatment interruption. After meeting enrollment criteria sixteen subjects with 3BNC117 sensitive virus (\<2μg/ml IC50) will receive two (Group A) or four (Group B) intravenous infusions of 3BNC117, administered at 30 mg/kg. In both dosing groups, antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) until week 12. Combination ART will be resumed at week 12. ART will be resumed sooner if plasma HIV-1 RNA level is ≥ 200 copies/ml or if CD4+ count drops \< 350 cells/μl and either result is confirmed upon repeat measurement. Participants will be followed weekly until week 12 for safety assessments and for monitoring plasma HIV-1 RNA levels (viral load). CD4+ T cell counts will be monitored every 2 weeks until week 12. Participants may remain off antiretroviral therapy after week 12, with weekly viral load monitoring, if viral rebound does not occur by week 12. Participants will be followed for a total of 36 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
3BNC117 infusions
Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.
The Rockefeller University
New York, New York, United States
Number of Participants With Virologic Rebound at 8 Weeks After Interruption of Antiretroviral Therapy
Virologic rebound is defined as confirmed plasma HIV-1 RNA level \> 200 copies/ml in two separate occasions
Time frame: 8 weeks
The Rate of Signs, Symptoms and Laboratory Abnormalities After 3BNC117 Infusions
The percentage of participants who experienced adverse events (e.g. signs, symptoms and laboratory abnormalities) following 3BNC117 infusions.
Time frame: 36 weeks
The Plasma Level of 3BNC117 at the Time of Viral Rebound.
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
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