NCT04860323

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

Name: Clinical Trial NCT04860323
Creator: HIV Vaccine Trials Network
Keywords: HIV Infection, Analytical Treatment Interruption, other, clinical trial, Botswana,Malawi,South Africa,Zimbabwe

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

HIV Vaccine Trials Network·ClinicalTrials.gov·otherRecruiting

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Study focus

Disease/Condition: HIV Infection
Drug/Device/Intervention: Analytical Treatment Interruption
Study type: Interventional
Intervention type: other

Sponsor & location

Primary sponsor: HIV Vaccine Trials Network
Location: Gaborone,Blantyre,Lilongwe,Durban,Durban,Johannesburg,Johannesburg,Rustenburg,Harare,Harare,Harare, Botswana,Malawi,South Africa,Zimbabwe

Timeline & enrollment

Phase: N/A
Start date: May 28, 2021
End date: Nov 01, 2022
Enrollment: 39 participants

Primary outcome

Time from the start of ATI to meeting ART re-initiation criteria,Percentage of participants who sustain post-treatment HIV control,Percentage of participants who experience adverse events (AEs),Percentage of participants who experience serious adverse events (SAEs),Percentage of participants who terminate the study early,Percentage of participants who discontinue ATI

Summary

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.

ICD-10 classifications

HIV disease resulting in other viral infectionsHuman immunodeficiency virus [HIV] diseaseHIV disease resulting in other bacterial infectionsAcute HIV infection syndromeUnspecified human immunodeficiency virus [HIV] disease

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT04860323
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT04860323 through Pure Global AI's free database. This phase not specified trial is sponsored by HIV Vaccine Trials Network and is currently Recruiting. The study focuses on HIV Infection. Target enrollment is 39 participants.

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