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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648516 on ClinicalTrials.gov