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 range18 Years – 100 Years
SexALL
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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."
✓. 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
✕
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.
. 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.