Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

NCT04963712 | Completed Early Phase 1

• 1 other identifier: Zadaxin-HIV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (2)

• Change in CD4+T cell counts

  Peripheral blood

  Measured on week 24

• Change in CD4/CD8 ratio

  Peripheral blood

  Measured on week 24

Secondary Outcomes (6)

• Change in CD4+T cell count and proportion

  Measured on week 0, 4, 8, 12, 24

• Change in CD8+T cell count and proportion

  Measured on week 0, 4, 8, 12, 24

• Change in proportions of T cell subsets

  Measured on week 0, 4, 8, 12, 24

• Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3

  Measured on week 0, 4, 8, 12, 24

• Change in PBMC sjTREC

  Measured on week 0, 4, 8, 12, 24

Study Arms (1)

Zadaxin-HIV(n=20)

EXPERIMENTAL

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.

Drug: Zadaxin

Interventions

Zadaxin 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.

Also known as: Thymosin α1

Zadaxin-HIV(n=20)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

Study Sites (1)

Fudan University

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 38233816 DERIVED

MeSH Terms

Interventions

Thymalfasin

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Hongzhou Lu, Ph.D

  Shanghai Public Health Clinical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants eligible for study received the same open label drug

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 15, 2021
• Study Start: September 1, 2021
• Primary Completion: July 22, 2022
• Study Completion: August 11, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)