HVTN 805/ HPTN 093

Status:Ongoing
Phase:Open Label
Principal Investigator(s):Shelly Karuna, Katharine Bar, Simba Takuva
Objective: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 Primary Objectives: 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 2) To evaluate the safety of ATI among HVTN 805/HPTN 093 participants Secondary Objectives: 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 development of anti-HIV immune responses that differ from those of placebo recipients, and whether these immune responses are associated with time to meeting criteria for ART re-initiation in participants undergoing ATI 2) 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 viral load in participants undergoing ATI 3) 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 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 Last updated July 12, 2022
Prevention Option(s):Antibody Related Research
Study Design:Open label
Official Code: NCT04860323
Trial Sponsors: ACTG, HPTN, HVTN, NIAID
Start Date
End Date
May 18, 2021
August 12, 2023
Enrollment:39
Age range: ↔ any
Population:Adolescents and Young People, Cisgender Men, Cisgender Women