A5385: An Observational Post-Intervention Cohort Destination Protocol

Treatment Experienced

This study is a two-step, non-interventional extension study for individuals participating in another interventional HIV cure trial (parent study) that includes an analytical treatment interruption (ATI) (stopping anti-HIV therapy [ART] while monitoring viral load). Participants will be individuals who achieved post-intervention control (PIC) (maintaining HIV suppression after treatment interruption) in their parent study.

 

Step 1 will consist of an extended ATI period in which PICs will be monitored for safety, viral, and immune outcomes. Time to viral rebound and restart of antiretroviral therapy (ART) will be measured. Participants will begin Step 2 if they meet ART restart criteria and will be monitored for safety, immune, and viral outcomes through 48 weeks after ART restart.

• To see if people who control HIV without ART after receiving an intervention can remain off ART safely.
• To see if predictors for post-intervention control can be identified.

• 18 years old or older, living with HIV.
• Enrollment in a qualifying (parent) study of curative or suppressive HIV therapy that included an ATI.
• CD4 count greater than 350.
• Completion of a parent study’s primary endpoint (main event at the study).
• Willingness to continue ATI for up to 96 weeks.
• Willingness to use barrier protection (male or female) during sexual activity throughout ATI.

Step 1 will consist of an extended ATI period (up to 96 weeks) in which participants will be monitored for safety, viral, and immune outcomes. Participants who meet ART restart criteria will enter Step 2 and be followed for 48 weeks.

 

Participants will be asked to undergo optional procedures at several time points.

This is an observational study; no treatment is provided.