Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
National Cancer Institute (NCI)
Summary
Background: Human immunodeficiency virus (HIV) infects CD4 T cells. There is no cure for HIV. People with HIV need to take daily medications called antiretroviral therapy (ART) to control their infection. ART stops HIV from infecting cells, but HIV does not go away. Some infected cells remain. If ART is stopped, then HIV levels will rise and infect more cells. Objective: To compare changes in the amount of virus in blood and lymph nodes after a short treatment interruption. Eligibility: Adults aged 18 years or older who are undergoing ART for HIV infection. Design: Participants will be screened with a physical exam, including blood tests. They will be assigned to 1 of 2 groups: One group will stay on ART. They will have 2 study visits: the first 45 days after screening, and the second 12 to 16 weeks later. They will have a PET/CT scan at each visit. A substance called a tracer will be injected into their arm. They will lie still on a table that moves through a doughnut-shaped machine. This process takes up to 2 hours. The other group will stop ART for no more than 90 days. This group will have 3 PET/CT scans over 8 months. Once they stop ART, they will visit the clinic weekly for blood tests. After restarting ART, they will continue to visit the clinic weekly until their HIV level is safe. All participants will have small samples of tissue taken from lymph nodes. They may also opt to provide semen samples or vaginal fluid. They may have samples taken of bone marrow or the fluid inside their spinal column.
Description
Study Description: HIV persistence during antiretroviral therapy (ART) is the principal obstacle preventing cure, and new studies are essential to understand mechanisms and sources of persistence. Analytic treatment interruption (ATI) studies provide opportunities for detailed evaluation of mechanisms underlying HIV persistence and viral rebound, and can be especially useful in characterizing early events in HIV reactivation. Early viral dynamics of rebound have not been extensively characterized however, in part because commercial assays for HIV viremia are relatively insensitive for changes…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: Participants must meet all of the following criteria to be eligible for this study: 1. Aged \>=18 years. 2. People with HIV-1 documented using US Food and Drug Administration-approved screening and confirmatory or supplemental assays in Centers for Disease Control and Prevention (CDC)-recommended testing strategies. 3. Established medical care outside NIH. 4. Able to provide informed consent. 5. Willing to allow samples to be stored for future research. 6. Willing to allow genetic testing. 7. Undergoing cART using recommended, alternative, or other regimens as defined b…
Interventions
- OtherAcute 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.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland