Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study - Trial NCT04801758
Access comprehensive clinical trial information for NCT04801758 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 30 participants.
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Study Focus
Sponsor & Location
HIV Vaccine Trials Network
Timeline & Enrollment
N/A
Feb 05, 2020
Jun 01, 2022
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 704/HPTN 085
 (NCT02716675).
 
 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
Data Source
ClinicalTrials.gov
NCT04801758
Non-Device Trial