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

NCT ID: NCT06660498

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-13
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pomalidomide

This arm will receive pomalidomide 2 mg oral capsules

Group Type: ACTIVE_COMPARATOR

Pomalidomide 2 mg

Intervention Type: DRUG

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.

Aspirin 75 mg

Intervention Type: DRUG

Auxiliary Medicinal Product

Placebo

This arm will receive placebo (oral capsules with no active drug)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Aspirin 75 mg

Intervention Type: DRUG

Auxiliary Medicinal Product

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Aspirin 75 mg

Auxiliary Medicinal Product

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Is of non-child-bearing potential defined as either:

• Age ≥ 50 years and naturally amenorrheic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential)
• Premature ovarian failure confirmed by a specialist gynecologist
• Previous bilateral salpingo-oophorectomy, or hysterectomy
• XY genotype, Turner syndrome, uterine agenesis
• Is of child-bearing potential with a negative pregnancy test at both Screening and Day 0 and agrees to use one of the following methods of contraception to avoid pregnancy:

• Complete abstinence from penile-vaginal intercourse from 4 weeks prior to administration of investigational medical product (IMP), throughout the study, and for at least 4 weeks after discontinuation of all study medications
• Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year
• Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject
• Approved hormonal contraception (Where other medications to be used in the study (e.g., efavirenz and darunavir) are known, or are likely, to significantly interact with systemic contraceptives, resulting in decreased efficacy of the contraceptive, then alternative methods of non-hormonal contraception are recommended)
• Any other method with published data showing that the expected failure rate is <1% per year
• Any contraception method must be used consistently, in accordance with the approved product label and for at least 4 weeks after discontinuation of study therapy.

A heterosexually active male participant, may be eligible to enter and participate in the study if he is:

• Willing to complete abstinence from penile-vaginal intercourse from 4 weeks prior to administration of IP, throughout the study, and for at least 4 weeks after discontinuation of all study medications
• willing to use an effective method of contraception (condom) including those who have had vasectomy performed
• agree on the use of an effective method of contraception with an effective failure rate of <1% by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day prior to the first dose and for at least 4 weeks after discontinuation of study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas A. Rasmussen, Associate professor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Royal Melbourne Hospital

Melbourne, , Australia

Site Status: NOT_YET_RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Australia; Denmark

Central Contacts

Thomas A. Rasmussen, Associate professor, MD, PhD

Role: CONTACT

thomrasm@rm.dk

459 350 8934

Other Identifiers

2024-512797-10-00 (EU CT no.)

Identifier Type: -

Identifier Source: org_study_id