Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 9, 2023

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2026

Conditions
HIV
Interventions
OTHER

Acute Treatment Interruption

Participants randomized to ATI will halt their ART medications starting 2 weeks (more or less 3 days) after the first imaging visit. This plan will be discussed with participants during the baseline visit. Patients will be contacted 1-3 days prior to ATI initiation. ATI may be delayed or cancelled if there are new safety concerns. HIV plasma viral levels and CD4 counts will be monitored every week during the ATI phase. If a participant meets any of the ART restart criteria during the ATI phase, then they will discontinue ATI and restart ART. Participants who do not meet restart criteria will remain off ART and continue to be monitored weekly until they have been on ATI for 90 days, and then will restart ART.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH