Status:
UNKNOWN
Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders
Lead Sponsor:
LI Taisheng
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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-infec...
Detailed Description
About 120 patients will be recruited from 4 HIV/AIDS clinical centers in China and randomized 1:1 into intervention group and placebo-controlled group. Triptolide wilfordii (20mg tid po) would be give...
Eligibility Criteria
Inclusion
- Continuous antiretroviral therapy \> 24 months ， and consistent HIV-RNA\< 40 copies/mL more than 12 months ;
- 18-65 years old;
- Male or female;
- Good adherence and promise to follow-up;
- Inform Consent signed;
- CD4 T cells less than 250/ul .
Exclusion
- Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
- hemoglobin (HGB) \< 9 g/dl 、 white blood cell (WBC) \< 2000/ul 、 granulin (GRN) \< 1000 /ul 、 platelet (PLT) \< 75000 /ul 、 Cr \>1.5x ULN 、 ALT or AST or alkaline phosphatase (ALP) \>3x upper limit of normal (ULN) 、 total bilirubin (TBIL) \>2x ULN 、 creatine kinase (CK) \> 2x ULN;
- Pregnant or breastfeeding woman or woman with pregnancy plan;
- Active drug-user;
- Severe neurological defects;
- Active alcohol abuse;
- Severe gastrointestinal ulcer .
- End-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc
- Those who are undertaking steroids, immunomodulator, anti-inflammatory agents
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01817283
Start Date
January 1 2013
End Date
March 1 2015
Last Update
March 25 2013
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730