HVTN 804/HPTN 095

Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who received VRC01 or placebo and became HIV-infected during HVTN 704/HPTN 085

Study Details

Protocol Status: Open to Accrual
Study Purpose:

Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who received VRC01 or placebo and became HIV-infected during HVTN 704/HPTN 085

Study Design:

An exploratory study of HIV-infected participants undergoing an analytical treatment interruption after receiving VRC01 or placebo infusions in HVTN 704/HPTN 085

Study Population:

HIV-1–infected HVTN 704/HPTN 085 participants who transitioned to Schedule 2 in that trial

Study Size:

16 - 46 participants expected

Study Duration:

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.

Treatment Regimen:

None. Drugs for anti-retroviral therapy (ART) and for pre-exposure prophylaxis (PrEP) will not be provided by the study or paid for using sponsor funds. Procedures for accessing external funding sources for PrEP and ART provision are detailed in the HVTN 804/HPTN 095 Study Specific Procedures (SSP).

Primary Objectives:

1) To evaluate the effect of 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 804/HPTN 095 participants

Secondary Objectives:

1) To evaluate the effect of 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 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 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