HPTN 081 Protocol Funding - Development Costs

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Investigator: Zvavahera Chirenje, MD, FRCOG
Sponsor: FHI 360

Location(s): Zimbabwe

Description

A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection

AMP stands for Antibody Mediated Prevention. AMP, also referred to as HVTN 703/HPTN 081, tests a new idea for HIV prevention. This is the idea of giving people antibodies to see if those antibodies will protect against HIV infection. In a vaccine study, participants receive a vaccine and are monitored to see if their bodies will make antibodies against HIV in response. In AMP, participants are given the antibodies directly. This is done through an infusion, which some people know better as getting an IV or getting a drip. This is the first study testing whether this antibody can prevent HIV infections in people. 

AMP is being conducted in women in seven (7) countries in sub-Saharan Africa. A parallel AMP trial, HVTN 704/HPTN 085, is simultaneously studying the effect of this antibody in MSM and transgender people in the U.S., Peru and Brazil.