NCT05419024RecruitingPhase 2
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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....
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Jun 2022
- Start date
- 9 Jan 2023
- Primary completion date
- 1 Aug 2029
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- HIV
- NCT number
- NCT05419024
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 9 Jan 2023 to the primary completion date, 1 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently undergoing therapy with drugs that, in the judgment of the investigators, may interfere with biodistribution of FDG, including prednisolone, valproate carbamazepine, phenytoin, phenobarbital, and catecholamines.
- Vaccination within the previous 4 weeks.
- Currently undergoing chronic systemic steroid therapy (corticosteroid nasal spray or inhaler, topical steroid use, and hormone replacement are acceptable).
Other illness
- Active intercurrent illness or infection, including fever \>38 degrees Celsius.
- Known history of initiating ART during the first year of infection with HIV. Participants will be considered to have initiated ART within 1 year of infection as defined by documented screening/confirmatory seroconversion (positive testing within one year of non-reactive HIV enzyme-linked immunosorbent assay).
- History of poorly controlled diabetes that, in the judgement of the investigators, would prevent completion of PET/CT scan.
- History of ATI within the past 1 year.
- Has comorbid illness for which, in the judgment of the investigators, an ATI will represent elevated risk.
- Active opportunistic infection as defined by the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
- Significant active substance abuse or psychiatric illness that may, in the judgment of the investigator, interfere with study visits or procedures.
- Allergy to planned anesthetic agents that are expected to be used. For local anesthetics, this is lidocaine. For sedation, this is midazolam and fentanyl.
- History of developing keloids.
- Active or chronic hepatitis B virus infection, with detectable hepatitis B surface antigen, hepatitis B virus DNA, or both.
- Active hepatitis C virus infection, with detectable virus RNA.
- History of HIV-associated dementia or progressive multifocal leukoencephalopathy.
- Documented ARV drug resistance that, in the judgment of the investigator, would pose a risk of virologic failure should additional mutations develop during the study.
- History of cardiovascular event or at high risk of an event (e.g., atherosclerotic cardiovascular disease score \>20%) by a currently accepted risk calculator such as the 2023 AHA Predicting Risk of Cardiovascular Disease Events (PREVENT) or the 2018 ASCVD Risk Estimator Plus.
- History of AIDS-defining illness according to CDC criteria within the past 3 years.
- Hepatic impairment: aminotransferase \>2.5 x the upper limit of normal or documented history of cirrhosis.
- Any condition that, in the judgment of the investigator, contraindicates participation in this study.
Lab values
- Renal impairment: HIV-related kidney disease or estimated glomerular filtration rate (eGFR) CKD-EPI equation \<60 mL/min/1.73 m\^2. For individuals undergoing therapy with cobicistat or integrase strand inhibitors, GFR may be estimated using cystatin C or creatinine.
Other
- Participants who meet any of the following criteria will be excluded from this study:
- Pregnant.
- Breastfeeding.
- Undergoing ART that is incompatible with an ATI.
- Has undergone PET/CT within the last 6 months.
- Contraindication to use of IV contrast.
Criteria the registry did not label
- INCLUSION CRITERIA:
- Participants must meet all of the following criteria to be eligible for this study:
- Aged \>=18 years.
- 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.
- Established medical care outside NIH.
- Able to provide informed consent.
- Willing to allow samples to be stored for future research.
- Willing to allow genetic testing.
- Undergoing cART using recommended, alternative, or other regimens as defined by "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV."
- Viral RNA \<40 copies/mL plasma by conventional assay for at least 3 years (blips \[transient increases within 6 weeks\] of \<200 copies/mL are allowable when succeeding viral levels return to \<40 copies/mL on subsequent testing).
- CD4 cell count \>=350 cells/microliter.
- Willing to interrupt ART for up to 90 days.
- Willing to use a barrier method of contraception, such as condoms or dental dams, when engaging in sexual activity, or remain abstinent during ATI and after re-initiating ART until viral re-suppression is achieved, to prevent pregnancy and transmission of HIV.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.