Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01817283
Status:
UNKNOWN
Last Update Posted:
2013-03-25
First Post:
2013-03-18
Brief Title:
Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders
Sponsor:
LI Taisheng
Organization:
Peking Union Medical College
Study Overview
Official Title:
Study of Triptolide Woldifiion T Cell Immune Activation and Inflammation Biomarkers in HIV-infected Immunological Non-responders
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
RECRUITING
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:
CACTrip12
Brief Summary:
This study is a prospective multicenter randomized placebo-controlled clinical trial to evaluate impact of Triptolide wilfordii on T cell immune activation and inflammation biomarkers in HIV-infected immunological non-responders
Detailed Description:
About 120 patients will be recruited from 4 HIVAIDS clinical centers in China and randomized 11 into intervention group and placebo-controlled group Triptolide wilfordii 20mg tid po would be given to invention group for 24 weeks T cell activation and inflammation biomarkers including CD8HLA-DRCD38 IL-6 D-Dimer and high-sensitivity C-reactive protein hsCRP protein degradation-1 PD-1 Ki67 soluble CD14 and CD163 PD-1 CCR5 and CD57 would be tested Patients in placebo-controlled group will change to take Triptolide wilfordii 20mg tid po for another 24 weeks All patients will be followed up till 48 weeks We hypothesis that Triptolide wilfordii might reduce immune activation and inflammation of HIV immunological non-responders and increase CD4 T cell count which provides a new strategy for treatment of HIV-infected immunological non-responders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None