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Wits RHI

HVTN 805/HPTN 093

Infectious Diseases

HVTN 805/HPTN 093: Antiretroviral Analytical Treatment Interruption (ATI) to Assess Immunologic and Virologic Responses in Participants Who Initiated ART in Early HIV Infection After Receiving VRC01 or Placebo in HVTN 703/HPTN 081

Rationale

Antiretroviral therapy (ART) has transformed the lives of people living with HIV by effectively suppressing viral replication. However, long-term reliance on ART presents challenges, including potential toxicity, drug resistance, stigma, and the need for lifelong adherence. The HVTN 805/HPTN 093 study aims to explore alternative strategies for managing HIV through an analytical treatment interruption (ATI). This approach examines the role of early ART initiation and the impact of broadly neutralizing monoclonal antibodies (bnAbs), such as VRC01, in supporting ART-free control of HIV.

Primary Objectives

  1. Evaluate ART-Free HIV Control:
    Assess the time until ART re-initiation and the ability of participants to sustain HIV control for 24 weeks or longer without ART.
  2. Ensure Safety of ATI:
    Monitor the safety of ATI by tracking laboratory measures, adverse events (AEs), serious adverse events (SAEs), and participant retention rates.

Study Design

  • Type: Exploratory study.
  • Participants: Individuals living with HIV who received early ART in the HVTN 703/HPTN 081 trial, with or without VRC01/placebo infusions.
  • Sample Size: 16–61 participants.
  • Duration: Study duration ranges from 13–18 months for most participants, with a maximum of up to 3 years for individuals maintaining extended viral control during ATI.
  • Sites: Multiple sites across Southern Africa, including Soweto HVTN CRS, Rustenburg CRS, and Gaborone CRS.

Investigators

  • Principal Investigator (PI): Dr Carrie-Anne Mathew.
  • Sub-Investigators:
    • Prof Sinead Delany-Moretlwe.
    • Dr Elizabeth Roos.
    • Dr Nicole Poovan.

Sponsors

  • Division of AIDS (DAIDS).
  • National Institute of Allergy and Infectious Diseases (NIAID).
  • National Institutes of Health (NIH).

Latest Update

April 2024

For more details about the HVTN 805/HPTN 093 study please email rhicomms@wrhi.ac.za

Study Brief

HVTN 805/HPTN 093