HIV: ATI Study Shows Limited Sustained Post-Treatment Viral Control

Trial results for an Analytical Treatment Interruption (ATI) study in HIV were posted on ClinicalTrials.gov on 2026-03-13, involving 13 participants.

Background

HIV infection necessitates lifelong antiretroviral therapy (ART) to suppress the virus and maintain health. Analytical Treatment Interruption (ATI) studies are conducted to explore the immune system's intrinsic ability to control HIV in the absence of ART, often after experimental interventions. This particular study investigated participants who had previously received either the VRC01 antibody or a placebo in the HVTN 703/HPTN 081 AMP Study and subsequently acquired HIV. The goal was to understand if prior exposure to VRC01 might influence their immune system's capacity to control the virus during a planned interruption of standard HIV medication.

Trial design

This completed study, designated as Phase NA, enrolled 13 participants to investigate HIV Infection. The trial's purpose was to evaluate viral and immune system responses during an Analytical Treatment Interruption (ATI) in participants who had previously received VRC01 (at either 10mg/kg or 30mg/kg) or placebo in the HVTN 703/HPTN 081 AMP Study (NCT02568215) and subsequently acquired HIV. Participants temporarily stopped their HIV medication to assess the duration until ART re-initiation criteria were met.

Key results

The trial reported several key measurements related to the duration of ART interruption and post-treatment control:

• For "Time to Meeting Criteria for ART Re-initiation":
  • In the VRC01 10mg/kg group, the median time was 17.1 Weeks.
  • In the VRC01 30mg/kg group, the median time was 10.1 Weeks.
  • In the Placebo group, the median time was 13.3 Weeks.
• For "Frequency of Sustained Post-treatment HIV Control, Defined as ≥ 24 Weeks Off ART Without Meeting ART Re-initiation Criteria":
  • In the VRC01 10mg/kg group, 1 Participant achieved sustained control.
  • In the VRC01 30mg/kg group, 0 Participants achieved sustained control.
  • In the Placebo group, 1 Participant achieved sustained control.
• Regarding adverse events:
  • For "Percentage of Participants Who Experience Adverse Events (AEs)":
    • In the VRC01 10mg/kg group, 5 Participants experienced AEs.
    • In the VRC01 30mg/kg group, 2 Participants experienced AEs.
    • In the Placebo group, 6 Participants experienced AEs.
  • For "Number of Participants Reporting Serious Adverse Events (SAEs)":
    • In the VRC01 10mg/kg group, 0 Participants reported SAEs.
    • In the VRC01 30mg/kg group, 0 Participants reported SAEs.
    • In the Placebo group, 0 Participants reported SAEs.

What this means

The results from this small analytical treatment interruption study indicate that prior exposure to the VRC01 antibody at either tested dose did not substantially prolong the time participants could remain off antiretroviral therapy compared to those who received placebo. The median times to ART re-initiation were relatively short across all groups, ranging from 10.1 to 17.1 Weeks. Furthermore, the frequency of sustained post-treatment HIV control (defined as ≥ 24 weeks off ART) was low, with only 1 participant in the VRC01 10mg/kg group and 1 participant in the placebo group achieving this benchmark. No serious adverse events were reported in any group, suggesting a manageable safety profile for the ATI itself in this cohort.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04860323, titled "Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study", were posted on 2026-03-13 on clinicaltrials.gov.