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

NCT06660498 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 2024-512797-10-00 (EU CT no.)
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 2

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

Keywords

Immune-enhancing therapy; HIV; ART; Analytical treatment interruption; Investigator-initiated

Outcome Measures

Primary Outcomes (2)

• Efficacy of treatment, measured as the time from ART cessation until meeting ART restart criteria.

  From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

• Safety of treatment, measured by the number of treatment-emergent adverse events (AEs) of grade 3 or higher that are probably or definitely related to the study treatment.

  From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

Secondary Outcomes (11)

• Safety, defined as all other treatment-emerging adverse events (AEs)

  From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

• Rebound viral kinetics during the ATI, including plasma HIV-1 RNA copies/mL doubling times

  From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

• The proportion of participants maintaining HIV-1 RNA levels below 1,000 copies/mL at the end of the ATI.

  From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

• The proportion of participants who have not met ART restart criteria at the end of the ATI.

  From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

• The frequency of peripheral blood CD4+ T cells containing total and intact HIV-DNA while on suppressive ART

  From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

Study Arms (2)

Pomalidomide

ACTIVE COMPARATOR

This arm will receive pomalidomide 2 mg oral capsules

Drug: Pomalidomide 2 mg; Drug: Aspirin 75 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Aspirin 75 mg

Interventions

Pomalidomide 2 mg 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.

Pomalidomide

Placebo 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.

Placebo

Aspirin 75 mg DRUG

Auxiliary Medicinal Product

Placebo; Pomalidomide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Documented HIV-1 infection * Age 18-70 years, both included. * Receiving combination ART for at least 1 year and being on the same ART regimen for at least 4 weeks at the screening visit * HIV-1 plasma RNA \<50 copies/mL for \>1 year and \<20 copies/mL at screening. Episodes of a single HIV plasma RNA \>50-500 copies/mL will not exclude participation if the subsequent HIV plasma RNA was \<50 copies/mL * CD4+ T cell count \>500 cells/uL at screening * Ability and willingness to provide informed consent and to continue ART throughout the study phase I and to discontinue ART at the commencement of study phase II. * All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) during the study. * A female participant, may be eligible to enter and participate in the study if she: * 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Royal Melbourne Hospital

Melbourne, Australia

Location

Aarhus University Hospital

Aarhus, Denmark

Location

MeSH Terms

Interventions

pomalidomide; Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Thomas A. Rasmussen, Associate professor, MD, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to pomalidomide 2 mg/d or matching placebo concurrent with aspirin 75 mg.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 28, 2024
• Study Start: May 13, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: September 2024-September 2026
• Access Criteria: Since the study was approved in September 2024, there has been open access to the study protocol, the statistical analysis plan, and the informed consent form through the CTIS platform.

Locations

DK (1); AU (1)