Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Public Health Clinical Center
• Treatments: Thymalfasin

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.