An Early Phase 1 interventional study of Zadaxin in HIV-1-infection, sponsored by Shanghai Public Health Clinical Center. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Shanghai Public Health Clinical Center · Early Phase 1, Interventional, and Treatment
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.
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.).
210 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.
This study's enrollment of 20 is below the median of 89 across 140 interventional studies indexed under HIV Seropositivity.
Browse HIV Seropositivity studies →Shanghai Public Health Clinical Center is the lead sponsor of 37 studies on the registry; 11 are open to participants now.
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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
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
Change in CD4+T cell counts
Peripheral blood
Time frame: Measured on week 24
Change in CD4/CD8 ratio
Peripheral blood
Time frame: Measured on week 24
Change in CD4+T cell count and proportion
Peripheral blood
Time frame: Measured on week 0, 4, 8, 12, 24
Change in CD8+T cell count and proportion
Peripheral blood
Time frame: Measured on week 0, 4, 8, 12, 24
Change in proportions of T cell subsets
Peripheral blood mononuclear cell
Time frame: Measured on week 0, 4, 8, 12, 24
Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3
Peripheral blood mononuclear cell
Time frame: Measured on week 0, 4, 8, 12, 24
Change in PBMC sjTREC
Peripheral blood mononuclear cell
Time frame: Measured on week 0, 4, 8, 12, 24
Change in HIV-1 RNA
Plasma
Time frame: Measured on week 0, 4, 8, 12, 24
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Public Health Clinical Center