HVTN 703/HPTN 081 Protocol Funding (PF)
Location(s): Kenya; Malawi; Mozambique; Tanzania; Zimbabwe; Botswana; South Africa
The first large-scale human trials to evaluate whether a bNAb called VRC01, given by infusion, is effective in preventing HIV acquisition.
⋅ The first of the two studies, HVTN 704/HPTN 085, will enroll 2,700 gay men and transgender individuals who have sex with men in the U.S., South America and Europe.
⋅ The second study, HVTN 703/HPTN 081, will enroll 1,500 sexually active women at 15 sites in Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania and Zimbabwe.
These placebo-controlled trials, jointly referred to as the AMP Studies, are almost identical in design. In addition to establishing the efficacy of bNAbs in preventing HIV infection, the AMP Studies will evaluate the safety and tolerability of the VRC01 infusion, and explore what concentration of the bNAb is required for effective prevention.