CAR-T Cell Therapy for HIV Patients
Official title: The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
Run by Guangzhou 8th People's Hospital · NCT03240328 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Guangzhou 8th People's Hospital Academic / other |
| Drugs / interventions | cART, CAR-T |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | October 4, 2017 |
| Main results expected | December 31, 2023 |
| Study ends | December 31, 2030 |
| Registry record updated | September 14, 2022 |
| Trial ID | NCT03240328 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with active hepatitis infections, serious chronic diseases, or those unable to adhere to treatment may not benefit from this study.
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 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.
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 gone: While CAR-T cell therapy has shown promise in other conditions, its application for HIV is still novel and under investigation.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.