Imaging and Biopsy of People Living with HIV-1 Undergoing Analytic Treatment Interruption (BATI)

Study Name

Imaging and Biopsy of People Living with HIV-1 Undergoing Analytic Treatment Interruption (BATI)

Study Number

NCT05419024 / NIH 000277

Goal of Study  

If you join this study, you will have a scan called PET/CT to find the location of HIV-infected cells. Infected cells need energy to make more HIV, and PET/CT uses radiation to show what parts of the body are using energy.

We will take blood and small samples of tissue (biopsies), and do research tests to measure HIV and immune system activity. We may also ask for small samples of bone marrow, cerebrospinal fluid, semen, or vaginal fluid. These are optional, though, so you can say no.

You and the other study participants will be randomly put into one of two groups. Which group you are in is up to chance, like flipping a coin. You have the same chance of being put in either group. One group will continue their antiretroviral therapy (ART) as normal. The second group will temporarily stop ART. This will be done under close medical supervision, and for no longer than 90 days.

When ART is stopped, the infected cells should start making more HIV. By comparing the research tests between the two groups, we hope to see where these cells were located. If you are in the group that stays on ART, then you will have 2 PET/CT scans about 12 to 16 weeks apart. If you are in the group to temporarily stop ART, then you will have 3 PET/CT scans over the course of up to 8 months. You will also have weekly study visits so we can measure your HIV and CD4 levels.

Study Design

We will enroll 12 people for this study. Six of them will be randomized to continue ART, and
the other 6 will temporarily stop ART for no more than 90 days.

Eligibility Criteria

  • You are at least 18 years of age and living with HIV
  • You have a CD4 t-cell count >350
  • You have had an undetectable HIV viral load for at least 3 years
  • You did not start ART within the first year of your HIV diagnosis
  • You are willing to be assigned, at random, to continuing your ART, or stopping ART under study supervision
  • You live within 50 miles of Bethesda, Maryland

Is Compensation Provided?  

 There is no cost, and subjects will be compensated. 

Visit ClinicalTrials.gov for details.

Participating in Research

Watch a series of short informational videos about participating in clinical trials. These videos are intended to help potential participants understand how research works, what questions they should consider asking, and things to think about when deciding whether or not to participate in a study.

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