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Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04963712
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Hongzhou Lu, Shanghai Public Health Clinical Center

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Zadaxin in the treatment of HIV-positive patients with immune reconstitution disorders. Researchers previously used Thymosin α-1 (Tα1) as an immune adjuvant for people infected with HIV-1 and found that Tα1 and Interferon-α (IFN-α) have a synergistic effect in immune enhancement. In addition, studies have found that the triple combination of Tα1, IFN-α and Zidovudine (AZT) has better tolerability, safety and efficacy. After treatment, patients have lower HIV RNA and more stable high CD4+ T cell counts. In addition, extensive studies on the administration of Tα1 in thymectomized mice have demonstrated its ability to promote immune reconstitution. The researchers hypothesized that Zadaxin has a better therapeutic effect on HIV-positive patients with immune reconstitution disorders, can increase the CD4+T cell count, reduce the viral load, and has better safety.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Zadaxin Phase 3

Detailed Description:
All patients received Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the second 22 weeks. It is still recommended to continue treatment until the end of the study. All subjects were given HAART treatment throughout. In 4th week, 8th week, 12th week and 24th week, perform 4 follow-up and record the changes in CD4+ T cell count, CD8+ T cell count, CD45 RO+ and RA+ in CD8+ and CD4+ cells, PBMC sjTREC, viral load, PBMC PD-1 and Tim-3. During the process, safety assessment is performed, including adverse events, electrocardiogram and a series of laboratory tests (blood routine, liver and kidney function, etc.).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants eligible for study received the same open label drug
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single-arm Cohort Study Evaluating the Safety and Efficacy of Thymalfasin (Zadaxin®) in the Treatment of HIV-positive Patients With Immune Reconstitution Disorders
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Zadaxin-HIV(n=20)
Study participants will be given Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the second 22 weeks.
Drug: Zadaxin
1.6 mg subcutaneous injection, once a day in the first 2 weeks, and 1.6 mg subcutaneous injection, twice a week in the second 22 weeks.
Other Name: Thymosin α1




Primary Outcome Measures :
  1. Change in CD4+T cell count [ Time Frame: Measured on week 24 ]
    Peripheral blood


Secondary Outcome Measures :
  1. Change in CD8+T cell count [ Time Frame: Measured on week 4, 8, 12 ]
    Peripheral blood

  2. Change in CD45 RO+ and RA+ in CD8+、CD4+ cell [ Time Frame: Measured on week 4, 8, 12, 24 ]
    Peripheral blood

  3. Change in PBMC sjTREC [ Time Frame: Measured on week 4, 8, 12, 24 ]
    Peripheral blood

  4. Change in HIV-1 RNA [ Time Frame: Measured on week 4, 8, 12, 24 ]
    Plasma

  5. Change in PBMC PD-1 and Tim-3 [ Time Frame: Measured on week 4, 8, 12, 24 ]
    Peripheral blood

  6. Change in CD4+T cell count [ Time Frame: Measured on week 4, 8, 12, 24 ]
    Peripheral blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years old;
  • HIV serology is positive;
  • Volunteer to participate;
  • CD4+T cell count >100 and <350 cells/mm3;
  • People who have received HAART treatment and the viral load is undetected for at least 2 years, but have immune reconstitution disorder;
  • Without active opportunistic infection;

Exclusion Criteria:

  • History of allergy or contraindications to Zadaxin;
  • Skin basal cell carcinoma, cervical carcinoma in situ or other concurrent tumors other than Kaposi's sarcoma;
  • The expected survival time is less than 1 year;
  • Women of childbearing age have a positive pregnancy test;
  • Major heart disease or central nervous system disease or other nervous system abnormalities;
  • ACTG-AIDS dementia syndrome staging score> 0.5;
  • Organ transplantation;
  • Received chemotherapy and radiotherapy for malignant tumors within 6 months;
  • Known immunomodulators (such as systemic steroids, interferons, interleukins) or other immunotherapy within 30 days before the start of the study;
  • Blood transfusion within 30 days before the start of the study;
  • Have a history of iritis, endophthalmitis, scleritis or retinitis;
  • Within 30 days before the screening assessment, accept any experimental treatment for HIV-positive patients with or without symptoms of infection;
  • Drug abuse;
  • The doctor's decision is that participation in the trial is not in the patient's best interests, or any situation that does not allow safe compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963712


Contacts
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Contact: Hongzhou Lu, M.D. +86-021-37990333 ext 3222 luhongzhou@fudan.edu.cn
Contact: Chaoyu Chen, M.D. +86-15858855310 ccy112359@163.com

Locations
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China, Shanghai
Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Hongzhou Lu, M.D.    +86-021-37990333 ext 3222    luhongzhou@fudan.edu.cn   
Contact: Chaoyu Chen, M.D.    +86-15858855310    ccy112359@163.com   
Sponsors and Collaborators
Shanghai Public Health Clinical Center
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Responsible Party: Hongzhou Lu, Professor, Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier: NCT04963712    
Other Study ID Numbers: Zadaxin-HIV
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Thymalfasin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs