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New treatment option for HIV
Official title Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
ClinicalTrials.gov ID: NCT05419024
What this study is testing
- What it's testing
- Background: Human immunodeficiency virus (HIV) infects CD4 T cells. There is no cure for HIV.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- Established medical care outside NIH.
- Able to provide informed consent.
You likely can't join if
- 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...
- Pregnant.
- Breastfeeding.
- Currently undergoing therapy with drugs that, in the judgment of the investigators, may interfere with biodistribution of FDG, including...
See the full eligibility criteria
Who can join
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.