CAR-T Cells for HIV Infection

Korábbi kezelés

• ART regimen that includes protease inhibitor(s) and/or AZT. These drugs may increase the toxicity of cyclophosphamide.

Más betegség

• 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
• 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

Egyéb

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• Unwillingness to abstain from sex or use barrier protection for any sexual activity during the treatment interruption.

• 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