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Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

Primary Purpose

HIV-1-infection

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Zadaxin
Sponsored by
Shanghai Public Health Clinical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1-infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zadaxin-HIV(n=20)

Arm Description

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 successive 22 weeks.

Outcomes

Primary Outcome Measures

Change in CD4+T cell counts
Peripheral blood
Change in CD4/CD8 ratio
Peripheral blood

Secondary Outcome Measures

Change in CD4+T cell count and proportion
Peripheral blood
Change in CD8+T cell count and proportion
Peripheral blood
Change in proportions of T cell subsets
Peripheral blood mononuclear cell
Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3
Peripheral blood mononuclear cell
Change in PBMC sjTREC
Peripheral blood mononuclear cell
Change in HIV-1 RNA
Plasma

Full Information

First Posted
July 7, 2021
Last Updated
July 15, 2023
Sponsor
Shanghai Public Health Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04963712
Brief Title
Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 22, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Public Health Clinical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Zadaxin® (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 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.
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 successive 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 and proportion, CD8+ T cell count and proportion, proportions of T cell subsets, PBMC sjTREC, proportions of exhauseted T cell expressed PD-1 and Tim-3, and HIV viral load. During the process, safety assessment is performed, including adverse events, electrocardiogram and a series of laboratory tests (blood routine, liver and kidney function, etc.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All participants eligible for study received the same open label drug
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zadaxin-HIV(n=20)
Arm Type
Experimental
Arm Description
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 successive 22 weeks.
Intervention Type
Drug
Intervention Name(s)
Zadaxin
Other Intervention Name(s)
Thymosin α1
Intervention Description
1.6 mg subcutaneous injection, once a day in the first 2 weeks, and 1.6 mg subcutaneous injection, twice a week in the successive 22 weeks.
Primary Outcome Measure Information:
Title
Change in CD4+T cell counts
Description
Peripheral blood
Time Frame
Measured on week 24
Title
Change in CD4/CD8 ratio
Description
Peripheral blood
Time Frame
Measured on week 24
Secondary Outcome Measure Information:
Title
Change in CD4+T cell count and proportion
Description
Peripheral blood
Time Frame
Measured on week 0, 4, 8, 12, 24
Title
Change in CD8+T cell count and proportion
Description
Peripheral blood
Time Frame
Measured on week 0, 4, 8, 12, 24
Title
Change in proportions of T cell subsets
Description
Peripheral blood mononuclear cell
Time Frame
Measured on week 0, 4, 8, 12, 24
Title
Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3
Description
Peripheral blood mononuclear cell
Time Frame
Measured on week 0, 4, 8, 12, 24
Title
Change in PBMC sjTREC
Description
Peripheral blood mononuclear cell
Time Frame
Measured on week 0, 4, 8, 12, 24
Title
Change in HIV-1 RNA
Description
Plasma
Time Frame
Measured on week 0, 4, 8, 12, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongzhou Lu, Ph.D
Organizational Affiliation
Shanghai Public Health Clinical Center
Official's Role
Study Director
Facility Information:
Facility Name
Fudan University
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

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