Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03403569
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2018-01-11
Brief Title:
Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Impact of Triptolide Wilfordii on Viral Suppression Immune Recovery and Immune Activation Biomarkers in Treatment-naive HIV-1 Infection a Randomized Double-blinded Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2020-03
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 traditional Chinese herbal medicine Triptolide Wilfordii has displayed remarkable effect on the treatment of autoimmune diseases such as rheumatoid arthritis Now that immunosuppression therapy has recently become a new strategy for HIV infection its reasonable to expect the anti-inflammatory effect of Triptolide Wilfordii in HIV infected patients So we designed a randomized double-blinded placebo-controlled study to explore the efficacy and safety of Triptolide Wilfordii in new-onset HIV infection
Detailed Description:
Acquired immune deficiency syndromeAIDS is a severe fatal disease caused by HIV infection Despite viral suppression achieved antiretroviral therapyART cannot ameliorate HIV-induced immune activation and the consequent non-AIDS complications including cardiovascular renal hepatic diseases Recently immunosuppression therapy has become the focus since it can suppress exorbitant immune activation and inflammation so as to reduce the risk of non-AIDS cardiovascular and central neural system complications Triptolide Wilfordii is a traditional Chinese herbal remedy and has long been used in the treatment of autoimmune diseases such as rheumatoid arthritis Moreover a recent study has shown that Triptolide Wilfordii combined with ART is associated with increased CD4 T cell counts and reduced immune activation in immunological non-responders who were defined as patients with CD4 cell counts350 cellsμl despite over 2 years of ART Hence we expect Triptolide Wilfordii to bring up similar improvement in treatment naïve HIV infection This randomized double-blinded placebo-controlled study is designed to investigate the safety and efficacy of Triptolide Wilfordii and hopefully provide evidence for a new treatment strategy
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?:
False
Is an FDA AA801 Violation?:
None