Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

  • End date
    Apr 1, 2022
  • participants needed
  • sponsor
    Shanghai Public Health Clinical Center
Updated on 15 September 2021


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 Thymosin -1 (T1) as an immune adjuvant for people infected with HIV-1 and found that T1 and Interferon- (IFN-) have a synergistic effect in immune enhancement. In addition, studies have found that the triple combination of T1, IFN- and Zidovudine (AZT) 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 T1 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 second 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, CD8+ T cell count, CD45 RO+ and RA+ in CD8+ and CD4+ cells, PBMC sjTREC, viral load, PBMC PD-1 and Tim-3. During the process, safety assessment is performed, including adverse events, electrocardiogram and a series of laboratory tests (blood routine, liver and kidney function, etc.).

Condition HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection
Treatment Ridaxian, Zadaxin
Clinical Study IdentifierNCT04963712
SponsorShanghai Public Health Clinical Center
Last Modified on15 September 2021


Yes No Not Sure

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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