Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

What Was Tested

The trial (early phase 1) is built around Thymosin Alpha-1.

It had 1 arm (groups): Zadaxin-HIV(n=20) (experimental).

The registry classes the interventions as drug.

More on the Plan

It is still recommended to continue treatment until the end of the study.

All subjects were given HAART treatment throughout.

During the process, safety assessment is performed, including adverse events, electrocardiogram and a series of laboratory tests (blood routine, liver and kidney function, etc.).

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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;.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Thymosin Alpha-1 study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-09-01 with completion listed for 2022-07-22.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in CD4+T cell counts (time frame: Measured on week 24). Change in CD4/CD8 ratio (time frame: Measured on week 24).

It also tracked 6 secondary outcomes, for example Change in CD4+T cell count and proportion, Change in CD8+T cell count and proportion, Change in proportions of T cell subsets, Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3, Change in PBMC sjTREC and Change in HIV-1 RNA.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Thymosin Alpha-1 in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymosin Alpha-1 compound page, all human trials.