Study Objectives

Primary Objectives

  • To evaluate the effect of early ART initiation, with or without having received VRC01 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.
  • To evaluate the safety of ATI among HVTN 805/HPTN 093 participants.

Secondary Objectives

  • To evaluate the effect of early ART initiation, with or without having received VRC01 in the immediate pre-HIV acquisition period and/or during early infection, on the development of anti-HIV immune responses and on the potential association of those immune responses with time to meeting criteria for ART re-initiation in participants undergoing ATI.
  • To evaluate the effect of early ART initiation, with or without having received VRC01 in the immediate pre-HIV acquisition period and/or during early infection, on HIV reservoir size before and after ATI, and whether HIV reservoir measurements are associated with time to meeting criteria for ART re-initiation in participants undergoing ATI.
  • To evaluate the effect of early ART initiation, with or without having received VRC01 in the immediate pre-HIV acquisition period and/or during early infection, on viral load in participants undergoing ATI.

Study Design: An exploratory study of participants living with HIV undergoing an analytical treatment interruption after early initiation of antiretroviral therapy (ART) following HIV acquisition in HVTN 703/HPTN 081, where they received VRC01 or placebo infusions.

Study Population: HVTN 703/HPTN 081 participants living with HIV who met criteria for transition to Schedule 2 or Schedule 3 in that trial.

Study Size: 16 – 61 participants.

Study Duration: Study duration is potentially indefinite for a participant maintaining 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.

Sponsors

  • Division of AIDS (DAIDS)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)
  • Department of Health and Human Services (DHHS) Bethesda, Maryland, USA