CAR-T Cells for HIV Infection

This study is testing a new approach for people with HIV infection using special immune cells called LVgp120duoCAR-T cells. These cells are designed to target HIV. Some participants will also receive a drug called cyclophosphamide before the LVgp12oCAR-T cells. The study aims to see how safe this treatment is and if it can help people control HIV without their usual antiretroviral therapy (ART) medications. You may be able to join if you are 18 to 65 years old, have HIV-1 infection, and have been on stable ART for at least 12 months. The study will look for serious side effects within one year and if participants can control HIV without ART for 36 weeks. The current recruitment status is unclear.

Study design: This is an open-label, dose-escalating study with three cohorts, meaning you and the researchers will know which treatment you are receiving. It plans to enroll 18 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Researchers will monitor participants for up to one year after treatment and assess HIV control for 36 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

CAR-T Cells for HIV Infection

Recruiting

PHASE1Ages 18–65InterventionalTreatment

Steven Deeks

~18 participants

Updated 2026-04-09 on ClinicalTrials.gov

What's tested:CyclophosphamideLVgp120duoCAR-T cells, low doseLVgp120duoCAR-T cells, high doseAnalytic Treatment Interruption

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of participants reporting a new Grade 3 or greater adverse event that is definitely, probably, or possibly related to study treatment within 1 year of product administration.

Measured over Within 1 year of product administration

+1 more outcome measured

Conditions

HIV Infections

Where it's being run

2 sites across 1 states

California2

Study leadership

Steven Deeks, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Rebecca Hoh

[email protected]

415-476-4082 · ext. 139

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Number of participants reporting a new Grade 3 or greater adverse event that is definitely, probably, or possibly related to study treatment within 1 year of product administration.Within 1 year of product administration
The primary safety outcome will be the number of participants reporting a new Grade 3 or greater adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, including signs/symptoms, lab toxicity or clinical event, that is definitely, probably, or possibly related to study treatment within 1 year of product administration.
Number of participants achieving post-treatment control within 36 weeks of product administration.Week 36
The primary efficacy outcome will be the proportion of individuals who achieve study-defined post-treatment control. The investigators will define post-treatment control in two ways. First, participants who fail to show any consistent rebound above 400 copies RNA/mL between Weeks 12 and Week 36 will be considered as having achieved post-treatment control. Second, participants who exhibit a rebound and eventually achieve 24 weeks of virus control will be considered as having achieved post-treatment control.

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