Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04963712
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2021-07-07
Brief Title:
Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder
Sponsor:
Shanghai Public Health Clinical Center
Organization:
Shanghai Public Health Clinical Center
Study Overview
Official Title:
A Prospective Single-arm Cohort Study Evaluating the Safety and Efficacy of Thymalfasin Zadaxin in the Treatment of HIV-positive Patients With Immune Reconstitution Disorders
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 CD4T cell count reduce the viral load and has better safety
Detailed Description:
All patients received Zadaxin 16 mg subcutaneous injection once a day in the first 2 weeks and changed frequency 16 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None