NCT06660498

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Pomalidomide 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.
DRUG	Placebo	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.
DRUG	Aspirin 75 mg	Auxiliary Medicinal Product

Timeline

• Start date: 2025-05-13
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-10-28
• Last updated: 2025-06-27

Locations

2 sites across 2 countries: Australia, Denmark