Can CAR-T cells free HIV patients from daily medication?
NCT ID NCT04648046
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether specially engineered immune cells (CAR-T cells) can control HIV in people who stop their regular antiretroviral drugs. 18 participants will receive a single infusion of their own modified cells, with some also getting a mild chemotherapy drug beforehand. After infusion, HIV medications are paused to see if the engineered cells can keep the virus in check. The main goals are safety and whether the virus stays suppressed for at least 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- genetically modified immune cells (CAR-T cells) targeting HIV
- What this could lead to
- If successful, this could allow people with HIV to stop daily antiretroviral therapy while keeping the virus under control.
- What could go wrong
- This is a very early, small trial (18 people) focused on safety. The CAR-T cells may not persist or control HIV, and there are risks from the conditioning chemotherapy and potential side effects.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Dec 2029
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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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.
Inclusion Criteria: * Male or female, age ≥ 18 and ≤ 65 years * HIV-1 infection * On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days, and on a stable regimen that does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks or any long-acting ART drug that may be active in the participant after ART interruption for up to one year, without plans to modify ART during the study period * Screening plasma HIV RNA levels below the limit of quantification on all available determinations in past 12 months (isolated single values ≥ 40 but \< 200 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations) * CD4+ T cell count nadir \> 300 cells/mm3 * Screening CD4+ T-cell count ≥ 500 cells/mm3 * Available ART treatment history and the capacity to construct an effective antiretroviral treatment regimen * Willing to pause ART as part of the study Exclusion Criteria: * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study * ART regimen that includes a long-acting anti-HIV drug and/or NNRTI that may be active in the participant for up to one year after ART interruption * ART regimen that includes protease inhibitor(s) and/or AZT. These drugs may increase the toxicity of cyclophosphamide. * Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers * History of or current active hepatitis B (HBV) infection defined as positive HBV surface antigen test. A positive anti-HBc regardless of HBsAg status. * Active hepatitis C (HCV) infection * Active or latent tuberculosis infection * Chronic liver disease * Active and poorly controlled atherosclerotic cardiovascular disease * Unwillingness to abstain from sex or use barrier protection for any sexual activity during the treatment interruption.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, Davis
RECRUITINGSacramento, California, 95817, United States
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Zuckerberg San Francisco General
RECRUITINGSan Francisco, California, 94110, United States
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