Actively Recruiting
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
Led by National Cancer Institute (NCI) · Updated on 2026-05-07
50
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with HIV-1 infection confirmed by FDA-approved tests
- Receiving established medical care outside NIH
- Able to provide informed consent
- Willing to allow storage of samples for future research
- Willing to undergo genetic testing
- On antiretroviral therapy (ART) as recommended or alternative regimens
- Viral RNA below 40 copies/mL plasma for at least 3 years (allowing blips below 200 copies/mL)
- CD4 cell count of 350 cells/microliter or higher
- Willing to interrupt ART for up to 90 days
- Willing to use barrier contraception or remain abstinent during ATI and after ART re-initiation until viral suppression is achieved
You will not qualify if you...
- Active illness or infection including fever above 38 degrees Celsius
- Started ART within the first year of HIV infection
- Pregnant or breastfeeding
- Taking medications that may interfere with FDG distribution (e.g., prednisolone, valproate, carbamazepine, phenytoin, phenobarbital, catecholamines)
- On ART regimens incompatible with treatment interruption
- Had PET/CT scan within the last 6 months
- Poorly controlled diabetes preventing PET/CT scan
- Vaccinated within the last 4 weeks
- Had treatment interruption within the past year
- Comorbid illness posing elevated risk during ATI
- Active opportunistic infections
- Significant substance abuse or psychiatric illness interfering with study
- Allergy to planned anesthetics (lidocaine, midazolam, fentanyl)
- On chronic systemic steroid therapy (except certain nasal, inhaled, topical, or hormone replacement steroids)
- Contraindications to IV contrast use
- History of keloid formation
- Renal impairment with eGFR below 60 mL/min/1.73 m2
- Active hepatitis B or C infections
- History of HIV-associated dementia or progressive multifocal leukoencephalopathy
- Documented antiretroviral drug resistance posing risk of virologic failure
- History or high risk of cardiovascular events
- AIDS-defining illness within the past 3 years
- Liver impairment with aminotransferase above 2.5 times normal or cirrhosis
- Any other condition that contraindicates study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
C
Chuen-Yen C Lau, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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