drugset / Trial / NCT02651376
Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients
NaSingle-groupOpen-labelTreatment
Summary
Combined antiretroviral therapy (cART) efficiently suppress viral replication in majority of AIDS patients. The morbidity and mortality of the disease has dramatically decreased over the past 20 years. However, chronic human immunodeficiency virus-1 (HIV-1) infection lead to profound immune defects in some advanced AIDS patients who often develop with severe opportunistic infections (OIs), severe cachexia and other deadly complications, which accounts for the major death group even under cART. Up-to-date, there are no effective immune interventions to restore host holistic immunity for advanced AIDS patients.
Timeline
- Start
- 2015-09
- Primary completion
- 2017-04
- Completion
- 2017-08
Publications
- Background 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.
- Background Hutter G. Stem cell transplantation in strategies for curing HIV/AIDS. AIDS Res Ther. 2016 Sep 13;13(1):31. doi: 10.1186/s12981-016-0114-y. eCollection 2016.
- Background Krishnan A. Stem cell transplantation in HIV-infected patients. Curr Opin HIV AIDS. 2009 Jan;4(1):11-5. doi: 10.1097/COH.0b013e32831a6fc9.
- Background Zhang Z, Fu J, Xu X, Wang S, Xu R, Zhao M, Nie W, Wang X, Zhang J, Li T, Su L, Wang FS. Safety and immunological responses to human mesenchymal stem cell therapy in difficult-to-treat HIV-1-infected patients. AIDS. 2013 May 15;27(8):1283-93. doi: 10.1097/QAD.0b013e32835fab77.
- Yang T, Xie Z, Xu Z, Tu B, Lu H, Huang H, Huang L, Zhang C, Gao L, Jin L, Ma P, Zou J, Liu L, Zhen C, Zhou C, Meng S, Li YY, Song JW, Yang S, Ai HS, Jiao Y, Shi M, Xu R, Wang FS. HLA-mismatched allogeneic adoptive immune therapy in patients with severely immunosuppressed AIDS: a multicenter, open-label, controlled, phase 2a study. Emerg Microbes Infect. 2024 Dec;13(1):2364744. doi: 10.1080/22221751.2024.2364744. Epub 2024 Jun 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic Adoptive Immune Therapy | Cell therapy | 2e+08 cells/kg | Intravenous |
| Subject | Allogeneic Adoptive Immune Therapy | Cell therapy | 3e+08 cells/kg | Intravenous |