Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

  • STATUS
    Recruiting
  • End date
    Apr 1, 2022
  • participants needed
    20
  • sponsor
    Shanghai Public Health Clinical Center
Updated on 15 September 2021

Summary

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.

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 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.).

Details
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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note