Status:
COMPLETED
Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
HIV-infection/AIDS
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ha...
Detailed 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 activa...
Eligibility Criteria
Inclusion
- 18\~65 years old;
- Male or female;
- Good adherence and promise to follow-up;
- Inform Consent signed;
- Positive for HIV antibody test or serum HIV-RNA positive for 2 times or more;
Exclusion
- Present opportunity infection defined according to national AIDS treatment guideline or active opportunistic infection(not stable within 14 days ) within 3 months before recruitment or AIDS-related carcinoma;
- Hemoglobin (HGB) \< 9 g/dl, white blood cell (WBC) \< 3000/ul, granulin (GRN) \< 1500 /ul, platelet (PLT) \< 75000 /ul, Cr \>1.5x upper limit of normal (ULN), ALT or AST or alkaline phosphatase (ALP) \>3x ULN, total bilirubin (TBIL) \>2x ULN;
- Pregnancy or breastfeeding;
- Woman with pregnancy plan;
- Severe organ dysfunction;
- Administration of immunosuppressor, immunomodulator(including thymocin) or systemic cytotoxic drugs within 6 months before recruitment.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT03403569
Start Date
September 1 2018
End Date
June 30 2021
Last Update
April 8 2022
Active Locations (7)
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1
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350025
2
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, China, 510060
3
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
4
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450015