CAR-T Cells for HIV Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, HIV/AIDS, CAR-T cells, HIV cure, HIV reservoir, Immunotherapy
Eligibility Criteria
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.
Sites / Locations
- University of California, DavisRecruiting
- Zuckerberg San Francisco GeneralRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Low Dose CAR-T Cells Only
Conditioning + Low Dose CAR-T Cells
Conditioning + High Dose CAR-T Cells
Participants will NOT undergo non-ablative conditioning with cyclophosphamide. A single dose of 3 x 10^5 cells/kg LVgp120duoCAR-T cells will be infused. ART will be interrupted immediately after infusion.
Participants will undergo non-ablative conditioning with cyclophosphamide. A single dose of 3 x 10^5 cells/kg LVgp120duoCAR-T cells will be infused. ART will be interrupted immediately after infusion.
Participants will undergo non-ablative conditioning with cyclophosphamide. A single dose of 1 x 10^6 cells/kg LVgp120duoCAR-T cells will be infused into the participant. ART will be interrupted immediately after infusion.