Using CMV-specific T cells to treat HIV/AIDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of chimeric antigen receptor (CAR) engineered T cells that are specifically designed to target HIV-1 in individuals living with the virus. The approach involves creating these CAR T cells from autologous cytomegalovirus (CMV)-specific T cells, which are expected to persist longer in the body due to ongoing stimulation by CMV antigens. Participants will be individuals with HIV-1 who are on stable antiretroviral therapy (ART) and have undetectable viral loads. The study aims to assess the safety and persistence of these engineered T cells in the body, potentially leading to improved outcomes for HIV treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must be ≥ 18 years of age at the time of screening;
* Karnofsky Performance Status (KPS) ≥ 70;
* Documented HIV-1 infection anytime prior to study entry.;
* On stable ART with undetectable HIV-1 RNA (i.e \< 20 copies /mL) for at least 48 weeks prior to screening (2 plasma HIV-1 RNA blips 25-200 copies/mL are allowable);
* CD4+ cell count ≥ 450 cells/μL;
* Adequate organ function;
* Willingness to interrupt ART regimen for 4 days prior to leukapheresis;
* Not pregnant or breastfeeding.

Exclusion Criteria:

* Concurrent illness or comorbid condition;
* History of resistance to two or more classes of antiretroviral drugs;
* History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• UCSD, Division of Infectious Diseases and Global Public Health
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: John H. Baird, MD — City of Hope Medical Center
• Study coordinator: Marvin Hanashiro
• Email: mhanashiro@health.ucsd.edu
• Phone: (619) 543-3740

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.