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Human Immunodeficiency VirusPhase 1/2NCT02651376

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

A Phase 1/2 study testing Conventional plus AAIT in people with Human Immunodeficiency Virus and Immunodeficiency, run by Beijing 302 Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Conventional plus AAIT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Sep 2015to Aug 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the detailed description

Advanced AIDS patients are usually characterized with CD4 T cells less than 200 cells/uL, including end-stage AIDS patients (CD4 T cells less than 50 cells/uL), and often accompanied with severe opportunistic infections (including tuberculosis, PCP, fungus and so on) and deadly complications.In this regard, advanced AIDS patients present a unique and special profound immune deficiency setting. Therefore, increasing attention and evidence have been paid to development of novel immune therapeutic strategies for those patients.

Immune cell therapy in combination with anti-infection and anti-HIV therapy may open a new direction for advanced AIDS patients, but single cell-based immune therapies do not work well for advanced AIDS patients. Over past 30 years, more than hundreds of AIDS patients with haematological malignancies received autologous or allogeneic hematopoietic stem cell transfusion (HSCT), and their survival rate had been improved to the levels equal to non-HIV patients; however, allogeneic HSCT is only limited to treat AIDS patients with lymphoma or leukemia. The only cured Berlin Patient, who suffered from both acute myeloid leukemia and chronic HIV-1 infection, was transplanted with homozygous CCR5 delta 32 allogeneic HLA-matched stem cells and acquired a long-term remission of both leukemia and AIDS. However, it is very difficult to find the HLA-identical HSCT with CCR5 delta 32 homogenous donors for AIDS patients in clinic. Granulocyte colony-stimulating factor (G-CSF)-mobilized donor peripheral blood mononuclear cells (MNCs) are a heterogeneous population of immune cells that have a potential role in immunomodulation and hemopoiesis. Here, we hypothesized that HLA-mismatched MNCs transfusion can be used to comprehensively restore or boost the host holistic immune system for advanced AIDS patients, to the degree similar as the allogeneic HSCT for leukemia patients.

The purpose of this study is to investigate the safety and initial efficacy of allogeneic adoptive immune therapy (AAIT) for advanced AIDS patients. 20 patients received i.v. transfusion one round (3 times) of 2.0-3.0*10E8 cells/kg of MNSs as the treated group. All of them received the conventional (anti-opportunistic infection and ART) treatment for AIDS. The side effects, symptom improvement, control of opportunistic infections and CD4 T cell numbers will be evaluated during the 48-week follow up.

Being tested
Conventional plus AAIT
Keywords
Immunodeficiency, Allogenic Mononuclear Cell Transplantation
Medical subject headings
Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional plus AAITCombination product

    Also called Conventional plus allogeneic adoptive immune treatment

    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.

Study groups in NCT02651376
Study groupRoleWhat they receive
Conventional plus AAITExperimentalParticipants received conventional treatment (anti-opportunistic infections and ART) plus a dose (3 times of MNCs) of AAIT.
Receives: Combination Product: Conventional plus AAIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Side effects

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

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

Secondary outcomes (3)

  1. The changes of clinical symptoms

    Marker for efficacy of treatment

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

  2. The changes of CD4 T cell counts

    Marker for host immunity

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

  3. The plasma RNA copies/mL

    Marker for HIV load

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02651376
Sponsor's protocol ID
Beijing302H-2
Status last verified
Sep 2015
First submitted
8 Sep 2015
Last updated
29 Aug 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26731468

  • 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.

    PubMed 27625700

  • Krishnan A. Stem cell transplantation in HIV-infected patients. Curr Opin HIV AIDS. 2009 Jan;4(1):11-5. doi: 10.1097/COH.0b013e32831a6fc9.

    PubMed 19339935

  • 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.

    PubMed 23925377

  • 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.

    PubMed 38935839

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Conventional plus AAIT in people with Human Immunodeficiency Virus and Immunodeficiency, run by Beijing 302 Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Side effects (time frame: At Baseline and week 1, 2, 3, 4, 8, 12, 16, 24, 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02651376, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.

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