NCT04963712·Early Phase 1·INTERVENTIONAL

Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

Thymosin Alpha-1 Other Completed

Status

Completed

Phase

Early Phase 1

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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.

Full detailed description

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.).

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

First posted
Jul 15, 2021
Study start
Sep 1, 2021
Primary completion
Jul 22, 2022
Study completion
Aug 11, 2022
Results posted
Not reported
Registry updated
Jul 18, 2023

Outcomes

What the study measures.

Primary outcomes

Change in CD4+T cell counts

Time frame · Measured on week 24

Peripheral blood

Change in CD4/CD8 ratio

Time frame · Measured on week 24

Peripheral blood