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Clinical trialNCT04860323CompletedInterventional

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

SponsorHIV Vaccine Trials NetworkEnrollment13HIV Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if they get HIV. This study will evaluate the viral and immune system responses in an Analytical Treatment Interruption (ATI), in participants who received VRC01 or placebo and got HIV while enrolled in HVTN 703/HPTN 081 (NCT02568215). Participants in this study will stop taking their HIV medication. They will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is unable to control the HIV or they meet other ART re-start criteria as noted in section "Detailed Description". While they are not taking HIV medication, their HIV levels will be tested frequently, and their health will be monitored closely. This is called an analytical treatment interruption, or an ATI. An ATI is an experimental procedure that is only used in carefully monitored research.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Botswana
  • Gaborone Crs

    Gaborone, Botswana

Malawi
  • Blantyre Crs

    Blantyre, Malawi

  • Malawi Crs

    Lilongwe, Malawi

South Africa
  • Caprisa Ethekwini Crs

    Durban, South Africa

  • Vulindlela Crs

    Durban, South Africa

  • Kliptown Soweto Crs

    Johannesburg, South Africa

  • Ward 21 Crs

    Johannesburg, South Africa

  • Rustenburg Crs

    Rustenburg, South Africa

Zimbabwe
  • Milton Park Crs

    Harare, Zimbabwe

  • Seke South Crs

    Harare, Zimbabwe

  • Spilhaus Crs

    Harare, Zimbabwe

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 May 2021
Primary completion
4 Feb 2025
Completion
4 Feb 2025
Last update posted
13 Mar 2026
Registered enrollment
13
Registry id
NCT04860323

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.