Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders
NCT ID: NCT01817283
Last Updated: 2013-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2013-01-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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placebo + cART
combined with antiretroviral therapy, the control group will take placebo 2 tabs tid per day lasting for 6 months and then switch to take Triplitode 2 tabs tid po for anther 6 months
Triptolide
Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.
cART
Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.
placebo
Placebo pills produced the same as Triptolide wilfordii.
Triptolide + cART
combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.
Triptolide
Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.
cART
Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.
Interventions
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Triptolide
Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.
cART
Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.
placebo
Placebo pills produced the same as Triptolide wilfordii.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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LI Taisheng
OTHER
Responsible Party
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LI Taisheng
Peking Union Medical College Hospital
Principal Investigators
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Tai sheng LI, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CACTRIP12
Identifier Type: -
Identifier Source: org_study_id
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