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Trial · Interventional

CompletedEarly phase 1Registry data

Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

NCTNCT04963712 (opens ClinicalTrials.gov in a new tab)Other idZadaxin-HIV
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Early phase 1
Enrollment
20 participants (actual)
Sponsor
Shanghai Public Health Clinical Center · Other gov
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
1 Sept 2021
Primary completion
22 Jul 2022
Completion
11 Aug 2022
First posted
15 Jul 2021
Last update posted
18 Jul 2023
Conditions
HIV-1-infection

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph Early 1

    Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

    NCT04963712

    1 Sept 2021 to 11 Aug 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ZadaxinDrug

Arms1

  • Experimental

    Zadaxin-HIV(n=20)

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in CD4+T cell counts

    Time frame · Measured on week 24

    Registry description

    Peripheral blood

  2. Change in CD4/CD8 ratio

    Time frame · Measured on week 24

    Registry description

    Peripheral blood

Secondary outcomes(6)

  1. Change in CD4+T cell count and proportion

    Time frame · Measured on week 0, 4, 8, 12, 24

    Registry description

    Peripheral blood

  2. Change in CD8+T cell count and proportion

    Time frame · Measured on week 0, 4, 8, 12, 24

    Registry description

    Peripheral blood

  3. Change in proportions of T cell subsets

    Time frame · Measured on week 0, 4, 8, 12, 24

    Registry description

    Peripheral blood mononuclear cell

  4. Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3

    Time frame · Measured on week 0, 4, 8, 12, 24

    Registry description

    Peripheral blood mononuclear cell

  5. Change in PBMC sjTREC

    Time frame · Measured on week 0, 4, 8, 12, 24

    Registry description

    Peripheral blood mononuclear cell

  6. Change in HIV-1 RNA

    Time frame · Measured on week 0, 4, 8, 12, 24

    Registry description

    Plasma

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2024

11 results

Role of thymosin α1 in restoring immune response in immunological nonresponders living with HIV.

Chen et al. 2024BMC infectious diseasescited by 10

PMID 38233816PMC10792804DOI 10.1186/s12879-024-08985-yPUB-38233816

CC BY11 results
Download PDFSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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