Safety and Efficacy of Allogenic Adoptive Immune Therapy for Immune Reconstitution in Chronic HIV-1 Infected Patients
NCT02648516 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-06-19
Summary
Combination antiretroviral therapy (ART) effectively suppresses viral replication, leading to a significant immune recovery and a dramatic reduction in the incidence of AIDS-defining events. However, approximately 20% of individuals who exhibit stable viral suppression by ART, but fail to achieve sufficient immune reconstitution and are considered immune nonresponders (INRs). These INRs often experience an increased risk of opportunistic infections and shorter life expectancy compared with matched immune responders.Therefore, efficiently treating these immune nonresponders has become one of the most difficult challenges in the clinic.
Conditions
- Human Immunodeficiency Virus
- Disorder of Immune Reconstitution
Interventions
- COMBINATION_PRODUCT
-
Conventional plus AAIT
Participants will receive ART and taken i.v., at a dose of 2-3\*10E8 MNCs/kg body at baseline, week 1 and 2.
Sponsors & Collaborators
-
Beijing 302 Hospital
lead OTHER
Principal Investigators
-
Wang Fu-Sheng · Beijing 302 Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2021-07-31
- Completion
- 2022-12-31
Countries
- China
Study Locations
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