drugset / Trial / NCT04963712

Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

NCT04963712

Phase 0 Completed 20 enrolled Shanghai Public Health Clinical Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-09-01
Primary completion
2022-07-22
Completion
2022-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Thymalfasin Peptide 1.6 mg Subcutaneous