Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption (NCT05419024) | Clinical Trial Compass
RecruitingPhase 2
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
United States50 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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."
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves stopping HIV treatment temporarily — something called an analytic treatment interruption — which could let the virus rebound in my blood and tissues. Given my current viral load and CD4 count, how risky would that kind of interruption be for my specific situation?
2The study is measuring how much HIV DNA and RNA increases in the blood and lymph nodes after just 10 days off treatment. What does my doctor think that short window tells us about HIV reservoirs, and how does that translate into any potential benefit for me personally?
3Since this is a Phase 2 trial, what is still unknown about the safety of stopping antiretroviral therapy for this study, and are there any warning signs that would cause the research team to restart my treatment early?
4The trial involves both imaging and biopsy of lymphoid tissue — what does that biopsy procedure actually involve, how invasive is it, and what are the realistic risks I should weigh before agreeing to it?
5Would my doctor consider my current standard treatment plan a better path right now, or does participating in this research align well enough with where I am in my HIV care that it's worth a serious conversation with the study team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fold increase in HIV nucleic acids (RNA and DNA) in blood or lymphoid compartments from baseline to 10 day ATI vs baseline to no ATI.
. 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).
Exclusion criteria
. 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.