Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 60

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

PhasePhase 1
Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment40 (estimated)
SponsorGuangzhou 8th People's Hospital
Academic / other
Drugs / interventionscART, CAR-T
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedOctober 4, 2017
Main results expectedDecember 31, 2023
Study endsDecember 31, 2030
Registry record updatedSeptember 14, 2022
Trial IDNCT03240328 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.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.