RecruitingPhase 1Phase 2NCT06660498

Pomalidomide as an Immune-enhancing Agent for the Control of HIV

Pomalidomide as an Immune-enhancing Agent for the Control of HIV (PEACH): An Investigator-initiated Phase I/IIb Clinical Trial in People Living With HIV on ART and During Analytical Treatment Interruption


Sponsor

University of Aarhus

Enrollment

32 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to evaluate the safety and efficacy of pomalidomide in HIV-1-infected individuals on ART and to determine the impact of pomalidomide on virological control in people living with HIV during an analytical treatment interruption.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether pomalidomide — a drug normally used for multiple myeloma — can boost the immune system's ability to control HIV in people who are already on effective antiretroviral (HIV) treatment. Participants will eventually undergo a supervised treatment interruption to see how well their immune system controls the virus. **You may be eligible if...** - You are between 18 and 70 years old with confirmed HIV-1 infection - You have been on the same antiretroviral therapy (ART) regimen for at least 4 weeks and on ART overall for at least 1 year - Your HIV viral load has been undetectable for over 1 year - Your CD4 cell count (immune cell count) is above 500 - You are willing to temporarily stop HIV treatment during the study's second phase **You may NOT be eligible if...** - Your HIV is not well controlled or recently changed regimens - You are pregnant, planning pregnancy, or breastfeeding - You have conditions that make you unable to safely stop ART 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

DRUGPomalidomide 2 mg

Participants will receive pomalidomide 2 mg/d concurrently with aspirin 75 mg for three cycles, each consisting of 21 days on and a minimum of 7 days off.

DRUGPlacebo

Participants will receive placebo concurrently with aspirin 75 mg for three cycles, each consisting of 21 days on and a minimum of 7 days off.

DRUGAspirin 75 mg

Auxiliary Medicinal Product


Locations(2)

Royal Melbourne Hospital

Melbourne, Australia

Aarhus University Hospital

Aarhus, Denmark

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NCT06660498


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