Status:
RECRUITING
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
HIV
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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 infec...
Detailed 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. An...
Eligibility Criteria
Inclusion
- 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.
- EXCLUSION CRITERIA:
- Participants who meet any of the following criteria will be excluded from this study:
- 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).
- Pregnant.
- Breastfeeding.
- 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.
- Undergoing ART that is incompatible with an ATI.
- Has undergone PET/CT within the last 6 months.
- History of poorly controlled diabetes that, in the judgement of the investigators, would prevent completion of PET/CT scan.
- Vaccination within the previous 4 weeks.
- 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.
- Currently undergoing chronic systemic steroid therapy (corticosteroid nasal spray or inhaler, topical steroid use, and hormone replacement are acceptable).
- Contraindication to use of IV contrast.
- History of developing keloids.
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
January 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05419024
Start Date
January 9 2023
End Date
August 1 2026
Last Update
November 10 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892