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Can a cancer drug help people with HIV pause their daily meds?

NCT ID NCT06660498

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether pomalidomide, a drug currently used for multiple myeloma, can help control HIV when people temporarily stop their standard antiretroviral therapy (ART). Thirty-two adults with well-controlled HIV will receive either pomalidomide or a placebo alongside low-dose aspirin. The goal is to see if pomalidomide can delay the need to restart ART by boosting the immune system's ability to suppress the virus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pomalidomide
What this could lead to
If it works, this could point toward a way for people with HIV to safely stop daily antiretroviral therapy for longer periods.
What could go wrong
This is an early-phase trial with only 32 participants, so results may not apply broadly. Pomalidomide can cause serious side effects, and the treatment interruption carries risks of viral rebound.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Royal Melbourne Hospital

    Melbourne, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.