Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

NCT ID: NCT04963712

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-08-11

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.).

Conditions

HIV-1-infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 successive 22 weeks.

Group Type: EXPERIMENTAL

Zadaxin

Intervention Type: DRUG

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.

Interventions

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 successive 22 weeks.

Intervention Type: DRUG

Other Intervention Names

Thymosin α1

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hongzhou Lu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongzhou Lu, Ph.D

Role: STUDY_DIRECTOR

Shanghai Public Health Clinical Center

Locations

Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

Chen C, Wang J, Xun J, Zhang X, Liu L, Song Z, Zhang R, Chen J, Lu H. Role of thymosin alpha1 in restoring immune response in immunological nonresponders living with HIV. BMC Infect Dis. 2024 Jan 17;24(1):97. doi: 10.1186/s12879-024-08985-y.

Reference Type: DERIVED

PMID: 38233816 (View on PubMed)

Other Identifiers

Zadaxin-HIV

Identifier Type: -

Identifier Source: org_study_id