HIV Vaccine Trials Network conducts a clinical trial of Analytical Treatment Interruption to Assess the Immune System's Ability to Control HIV
HIV Vaccine Trials Network is commencing recruitment for the clinical trial of the 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.
The condition is HIV Infection.
A new clinical trial is recruiting patients in the following locations: .
The trial officially began on the March 2021 and is planned to complete on June 2022.
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.
The population that can be enrolled into this study includes:
- Estimated date of HIV-1 acquisition within 8 weeks of participant's last HVTN 704/HPTN 085 infusion.
- Initiated ART within 28 weeks of HVTN 704/HPTN 085 HIV-1 date of diagnosis.
- Receiving continuous ART for at least 1 year. ART interruptions of up to 7 days and ≥ 90 days prior to enrollment are acceptable. Within- and between-class changes in ART within the previous year are acceptable.
- If on an NNRTI, willingness and ability to switch to a PI- or INSTI-containing regimen for at least 4 weeks prior to ART interruption.
- Willingness to interrupt ART for up to 24 weeks or up to the time of meeting ART re-initiation criteria.
- Willingness to re-initiate ART upon meeting study ART re-initiation criteria.
The full list can be viewed at the link below.
National Institute of Allergy and Infectious Diseases (NIAID), HIV Prevention Trials Network, AIDS Clinical Trials Group are the collaborators in this clinical trial.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04801758
