Safety and Efficiency of Allogeneic Adoptive Immune Therapy for Advanced AIDS Patients

302-2019-05

Combined antiretroviral therapy (ART) efficiently suppresses viral replication and markedly decreases mortality among patients with HIV-1 infection/AIDS. While the advanced AIDS patients with CD4+T cell count less than 200 cells/µL often develop seriously opportunistic infections (OIs), severe wasting syndrome, and other fatal complications, which are the major causes of death in these patients. There has been no effective immune therapy for advanced AIDS patients who had a high mortality rate even in the era of cART. This clinical trail is to inspect the efficiency of allogeneic adoptive immune therapy for advanced AIDS patients.

2019-10-11

2023-12-30

2024-12-30

Recruiting

Early phase I

240

Inclusion Criteria: 1. Male or female, aged at 18 years (including) -65 years old 2. Advanced AIDS patients with AIDS-related events 3. Advanced patients with CD4 count less than or equal to 200 cells/uL, including end-stage patients with CD4 count less than or equal to 50 cells/uL before entry and at screening 4. Sign informed consent, do not participate in other clinical trails during the period Exclusion Criteria: 1. Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures 2. Combined with other serious organic diseases while didn't related with AIDS 3. HIV-2 infection 4. Allergic to blood products 5. Under long term immunosuppressive therapy 6. Combined with malignant tumors 7. Drug addicts within half-one year before the test 8. Poor compliance to antiviral therapy; take part in other clinical trials at present

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2024-01-05