RecruitingPhase 2NCT05419024

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption

Sponsor

National Cancer Institute (NCI)

Enrollment

50 participants

Start Date

Jan 9, 2023

Study Type

INTERVENTIONAL

Conditions

HIV

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is imaging and analyzing tissue from people with HIV who are temporarily stopping their antiretroviral medication as part of a controlled research process (called analytic treatment interruption). The aim is to better understand where HIV hides in the body and how it re-activates, which could help develop a cure. **You may be eligible if...** - You are 18 or older - You have confirmed HIV-1 infection - You have been stably suppressed on antiretroviral treatment (undetectable viral load) - You are willing to temporarily stop HIV medications under close medical supervision as part of the study **You may NOT be eligible if...** - You have any active serious infections or cancers - You have significant heart, liver, or kidney problems - You have immune cell counts too low to safely pause medication - You are pregnant or breastfeeding - You have a history of serious HIV-related illnesses that make pausing treatment risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAcute Treatment Interruption

Participants randomized to ATI will halt their ART medications starting 2 weeks (more or less 3 days) after the first imaging visit. This plan will be discussed with participants during the baseline visit. Patients will be contacted 1-3 days prior to ATI initiation. ATI may be delayed or cancelled if there are new safety concerns. HIV plasma viral levels and CD4 counts will be monitored every week during the ATI phase. If a participant meets any of the ART restart criteria during the ATI phase, then they will discontinue ATI and restart ART. Participants who do not meet restart criteria will remain off ART and continue to be monitored weekly until they have been on ATI for 90 days, and then will restart ART.