Allogeneic Adoptive Immune Therapy for Advanced AIDS Patients

NCT04098770 | Unknown Phase 2 DMC

• 1 other identifier: 302-2019-05
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AIDS Patients

Keywords

AIDS patients; Safety; Efficiency; Immune Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• The change of survival between AAIT treatment group and conventional group

  Marker for efficacy of treatment

  At week 24, 48 and 96

Other Outcomes (4)

• Side effects in the AAIT treatment group

  At Baseline, week 1, 2 , 4 and 24

• The occurence of clinical events including AIDS-related events and non-AIDS related events in the two groups

  At baseline, week 24, 48, 84 and 96

• The change of plasma RNA copies/mL between AAIT treatment group and conventional group

  At Baseline, week 1, 4, 12, 24, 48, 84 and 96

Study Arms (2)

Conventional treatment plus Allogeneic Adoptive Immune Therapy

EXPERIMENTAL

Participants will receive conventional treatment (anti-opportunistic infections, cART and other treatments) plus a dose (2-3 times) of Allogeneic Adoptive Immune Therapy

Biological: Allogeneic Adoptive Immune Therapy

Conventional treatment

NO INTERVENTION

Without Allogeneic Adoptive Immune Therapy but conventional treatment (anti-opportunistic infections , cART and other treatments) should be received

Interventions

Allogeneic Adoptive Immune Therapy BIOLOGICAL

A dose (2-3 times) of AAIT was added on conventional treatment for advanced AIDS patients

Conventional treatment plus Allogeneic Adoptive Immune Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged at 18 years (including) -65 years old
• Advanced AIDS patients with AIDS-related events
• 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
• Sign informed consent, do not participate in other clinical trails during the period

You may not qualify if:

• Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures
• Combined with other serious organic diseases while didn't related with AIDS
• HIV-2 infection
• Allergic to blood products
• Under long term immunosuppressive therapy
• Combined with malignant tumors
• Drug addicts within half-one year before the test
• Poor compliance to antiviral therapy; take part in other clinical trials at present

Sponsors & Collaborators

• Beijing 302 Hospital: lead
• The 6th people's Hospital of Xinjiang province: collaborator
• The 4th people's hospital of Nanning City: collaborator
• The 3th people's hospital of Shenzhen City: collaborator
• Shanghai Public Health Clinical Center: collaborator
• Yunnan Provincial Hospital of Infectious Diseases: collaborator

Study Sites (1)

Beijing 302 Hospital of China

Beijing, Beijing Municipality, 100039, China

RECRUITING

Related Publications (7)

• 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, 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.

  PMID: 19213682 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

• 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.

  PMID: 6131294 BACKGROUND

• 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.

  PMID: 6384784 BACKGROUND

• 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.

  PMID: 1975487 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

Study Officials

• Fu-Sheng Wang, MD

  Beijing 302 Hospital

  STUDY DIRECTOR

Central Study Contacts

Ruonan Xu, MD

CONTACT

86-10-66933333; xuruonan2004@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 23, 2019
• Study Start: October 11, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)