Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

HIV-1-infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963712
• Other study ID #: Zadaxin-HIV
• Status: Completed
• Phase: Early Phase 1
• Start date: September 1, 2021
• Est. completion date: August 11, 2022

Study information

• Verified date: July 2023
• Source: Shanghai Public Health Clinical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 11, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Seropositivity
• HIV-1-infection

Intervention

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 successive 22 weeks.

Locations

Country	Name	City	State
China	Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CD4+T cell counts	Peripheral blood	Measured on week 24
Primary	Change in CD4/CD8 ratio	Peripheral blood	Measured on week 24
Secondary	Change in CD4+T cell count and proportion	Peripheral blood	Measured on week 0, 4, 8, 12, 24
Secondary	Change in CD8+T cell count and proportion	Peripheral blood	Measured on week 0, 4, 8, 12, 24
Secondary	Change in proportions of T cell subsets	Peripheral blood mononuclear cell	Measured on week 0, 4, 8, 12, 24
Secondary	Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3	Peripheral blood mononuclear cell	Measured on week 0, 4, 8, 12, 24
Secondary	Change in PBMC sjTREC	Peripheral blood mononuclear cell	Measured on week 0, 4, 8, 12, 24
Secondary	Change in HIV-1 RNA	Plasma	Measured on week 0, 4, 8, 12, 24