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

Zadaxin-HIV

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.

2021-09-01

2022-07-22

2022-08-11

Completed

Early phase I

20

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.

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2023-07-18