Can a cancer drug help people with HIV pause their daily meds?
NCT ID NCT06660498
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
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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 Hide 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
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Other studies related to the condition(s) this trial covers.
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