Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients

NCT02651376 | Completed Phase 1 DMC

• 1 other identifier: Beijing302H-2
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Human Immunodeficiency Virus; Immunodeficiency

Keywords

Immunodeficiency; Allogenic Mononuclear Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Side effects

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  At Baseline and week 1, 2, 3, 4, 8, 12, 16, 24, 48

Secondary Outcomes (3)

• The changes of clinical symptoms

  At Baseline and week 1, 2, 3, 4, 8, 12, 16, 24,48

• The changes of CD4 T cell counts

  At Baseline and week 1, 2, 3, 4, 8, 12, 16, 24, 48

• The plasma RNA copies/mL

  At Baseline and at week 4, 12, 24, 48

Study Arms (1)

Conventional plus AAIT

EXPERIMENTAL

Participants received conventional treatment (anti-opportunistic infections and ART) plus a dose (3 times of MNCs) of AAIT.

Combination Product: Conventional plus AAIT

Interventions

Conventional plus AAIT COMBINATION_PRODUCT

Participants received conventional (anti-opportunistic infections and ART) treatment and taken i.v., at a roud (3 times) of 2-3\*10E8 MNCs/kg body at baseline, week 1 and 2.

Also known as: Conventional plus allogeneic adoptive immune treatment

Conventional plus AAIT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Severe immunodeficiency patients with chronic HIV-1 infection
• 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
• With or withour serious complications
• Ability and willingness to provide informed consent

You may not qualify if:

• Combined with other serious organic diseases, mental illness, including any uncontrolled clinical significance of urinary, respiratory, circulation, nerve, spirit, digestive, endocrine and immune system disease, lymphoma, malignant tumor of blood system etc;
• Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures
• Allergic to blood products
• Drug addicts within one year before the test
• Poor compliance to antiviral therapy; take part in other clinical trials at present, may be contrary to the treatment plan; unable or unwilling to provide informed
• Other serious conditions that may hamper clinical trials

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Related Publications (5)

• 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.

  PMID: 26731468 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.

  PMID: 27625700 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.

  PMID: 19339935 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.

  PMID: 23925377 BACKGROUND

• 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.

  PMID: 38935839 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes

Interventions

Congresses as Topic; AaIT neurotoxin, Androctonus australis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Fu-Sheng Wang

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: January 11, 2016
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2015-09