Study Title: Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081.
Study summary:
This is an antiretroviral analytical treatment interruption (ATI) study to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081. The primary objectives of the study are 1) To evaluate the effect of early ART initiation, with or without VRC01 received in the immediate pre-HIV acquisition period and/or during early infection, on the time to meeting ART re-initiation criteria in participants undergoing ATI; and 2) To evaluate the safety of ATI among HVTN 805/HPTN 093 participants. The study duration is potentially indefinite for a participant maintaining extreme and extended viral control during ATI. Study duration for most participants is expected to be 13-18 months. The maximum anticipated duration for any participant is expected to be approximately 2½ to 3 years.
Location: Milton Park CRS, Seke South CRS, Spilhaus CRS
HVTN
Current Study
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