Clinical Trials Logo

Clinical Trial 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, it's 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.


Clinical Trial Description

Acquired immune deficiency syndrome(AIDS) is a severe fatal disease caused by HIV infection. Despite viral suppression achieved, antiretroviral therapy(ART) 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 counts<350 cells/μl 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 Design


Related Conditions & MeSH terms


NCT number NCT03403569
Study type Interventional
Source Peking Union Medical College Hospital
Contact
Status Completed
Phase Phase 3
Start date September 1, 2018
Completion date June 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT00787696 - Healthy Teen Girls: HIV Risk Reduction Phase 1/Phase 2
Completed NCT02433743 - Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA N/A
Recruiting NCT02753049 - Adherence Connection for Counseling, Education, and Support N/A
Completed NCT01360762 - Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study Phase 3
Recruiting NCT03147859 - Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection Phase 2
Recruiting NCT04297488 - Probiotic Supplementation for Those Immune Non-responders With HIV-1 Infection N/A
Completed NCT01827540 - Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam Phase 1
Completed NCT01475890 - Vitamin D Supplementation in HIV Phase 2/Phase 3
Recruiting NCT05947539 - Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention N/A
Withdrawn NCT01442428 - Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial Phase 2/Phase 3
Completed NCT02496793 - Community-Based Peer Facilitator Intervention (Zimbabwe) N/A
Completed NCT03069235 - Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program N/A
Completed NCT03794648 - The Effectiveness of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Adherence to HIV Medication N/A
Withdrawn NCT04183738 - Inflammation and Co-Infections in D²EFT Phase 4
Enrolling by invitation NCT03919695 - Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda N/A
Recruiting NCT04215926 - NAFLD in HIV-infected Patients
Completed NCT01406626 - Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care N/A
Completed NCT04371835 - COHIVE: Coronavirus (COVID-19) Outcomes in HIV Evaluation in Resource Limited Settings
Completed NCT01140633 - Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda N/A
Enrolling by invitation NCT04373551 - WeExPAnd: PrEP Demonstration Project Among Women at Risk for HIV Infection - Preexposure Prophylaxis (PrEP) N/A