AIDS Patients Clinical Trial
Official title:
Safety and Efficiency of Allogeneic Adoptive Immune Therapy for Advanced AIDS Patients
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
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China | Beijing 302 Hospital of China | Beijing | Beijing |
Lead Sponsor | Collaborator |
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Beijing 302 Hospital | Shanghai Public Health Clinical Center, The 3th people's hospital of Shenzhen City, The 4th people's hospital of Nanning City, The 6th people's Hospital of Xinjiang province, Yunnan Provincial Hospital of Infectious Diseases |
China,
Davis KC, Hayward A, Ozturk G, Kohler PF. Lymphocyte transfusion in case of acquired immunodeficiency syndrome. Lancet. 1983 Mar 12;1(8324):599-600. doi: 10.1016/s0140-6736(83)92855-6. No abstract available. — View Citation
Hutter G, Nowak D, Mossner M, Ganepola S, Mussig A, Allers K, Schneider T, Hofmann J, Kucherer C, Blau O, Blau IW, Hofmann WK, Thiel E. Long-term control of HIV by CCR5 Delta32/Delta32 stem-cell transplantation. N Engl J Med. 2009 Feb 12;360(7):692-8. doi: 10.1056/NEJMoa0802905. — View Citation
Krishnan A. Stem cell transplantation in HIV-infected patients. Curr Opin HIV AIDS. 2009 Jan;4(1):11-5. doi: 10.1097/COH.0b013e32831a6fc9. — View Citation
Kuritzkes DR. Hematopoietic stem cell transplantation for HIV cure. J Clin Invest. 2016 Feb;126(2):432-7. doi: 10.1172/JCI80563. Epub 2016 Jan 5. — View Citation
Lane HC, Masur H, Longo DL, Klein HG, Rook AH, Quinnan GV Jr, Steis RG, Macher A, Whalen G, Edgar LC, et al. Partial immune reconstitution in a patient with the acquired immunodeficiency syndrome. N Engl J Med. 1984 Oct 25;311(17):1099-103. doi: 10.1056/NEJM198410253111706. No abstract available. — View Citation
Lane HC, Zunich KM, Wilson W, Cefali F, Easter M, Kovacs JA, Masur H, Leitman SF, Klein HG, Steis RG, et al. Syngeneic bone marrow transplantation and adoptive transfer of peripheral blood lymphocytes combined with zidovudine in human immunodeficiency virus (HIV) infection. Ann Intern Med. 1990 Oct 1;113(7):512-9. doi: 10.7326/0003-4819-113-7-512. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Side effects in the AAIT treatment group | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | At Baseline, week 1, 2 , 4 and 24 | |
Other | The occurence of clinical events including AIDS-related events and non-AIDS related events in the two groups | Marker for efficacy of treatment | At baseline, week 24, 48, 84 and 96 | |
Other | The change of plasma RNA copies/mL between AAIT treatment group and conventional group | Marker for HIV viral load | At Baseline, week 1, 4, 12, 24, 48, 84 and 96 | |
Other | The change of plasma HIV DNA between AAIT treatment group and conventional group | Changes of HIV DNA in PBMC | At Baseline and week 1, 12, 24 and 48 | |
Primary | The change of CD4+ T cell count between AAIT treatment group and conventional group | Marker for host immunity | At Baseline , week 4,12, 24, 48 and 96 | |
Primary | The change of survival between AAIT treatment group and conventional group | Marker for efficacy of treatment | At week 24, 48 and 96 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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