CAR-T Cell Therapy for HIV Patients
The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
This study tests if a new CAR-T cell therapy can safely help HIV patients who have their virus under control by boosting their immune system to fight the virus better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Guangzhou 8th People's Hospital Academic / other |
| Drugs / interventions | cART, CAR-T |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03240328 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of CAR-T cell therapy in HIV patients who have successfully suppressed their viral load with combined antiretroviral therapy (cART). The approach aims to enhance the reconstitution of HIV-specific immune function, which is crucial for eradicating the HIV reservoir. Participants will be monitored for adverse events, changes in HIV-1 reservoirs, and immune response indicators. The study focuses on utilizing genetically engineered CAR-T cells to target and eliminate HIV-infected cells.
Who should consider this trial
Good fit: Ideal candidates are HIV-infected individuals who have been on cART for over 12 months with a viral load below 50 copies/ml and a CD4 cell count above 350 cells/µl.
Not a fit: Patients with active hepatitis infections, serious chronic diseases, or those unable to adhere to treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could lead to a functional cure for HIV by improving the immune response against the virus.
How similar studies have performed: While CAR-T cell therapy has shown promise in other conditions, its application for HIV is still novel and under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. HIV infection confirmed. 2. Receiving cART more than 12 months. 3. HIV viral-load \< 50 copies/ml and CD4 cell count more than 350 cells/ul. 4. Without serious liver, heart, liver and kidney diseases. 5. The subjects know about the study and volunteer to attend the research and sign the informed consent. Exclusion Criteria: 1. With active HBV or HCV infection, or serious opportunistic infections. 2. With serious chronic disease such like diabetes, the mental illness,et al 3. History of suffering from pancreatitis during cART. 4. Pregnant or breast-fed. 5. With poor adherence. 6. Unable to complete follow up.
Where this trial is running
Guangzhou, Guangdong
- Guangzhou 8th People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Cai Weiping, Bachelor — Guangzhou 8th People's Hospital
- Study coordinator: Li Linghua, Doctor
- Email: llheliza@126.com
- Phone: 020-83710825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.