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NCT05419024 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of HIV, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
50
Enrollment target
1
Study location

NCT05419024 is a Phase 2 study of HIV that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05419024, a Phase 2 study of HIV, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
50 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • OTHER Acute Treatment Interruption

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-01-09
Est. Completion 2026-08-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT05419024

The ClinicalTrials.gov registry entry for NCT05419024 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (89% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Acute Treatment Interruption is the first listed.

NCT05419024 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT05419024 about?

NCT05419024 is a clinical study titled "Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption". 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 A...

What is the current status of trial NCT05419024?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-01-09. Estimated completion is 2026-08-01.

What conditions does trial NCT05419024 study?

This clinical trial studies the following conditions: HIV.

What interventions are being tested in trial NCT05419024?

The interventions under investigation include: Acute Treatment Interruption (OTHER).

Who is sponsoring clinical trial NCT05419024?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05419024 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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