- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01817283
Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders (CACTrip12)
March 22, 2013 updated by: LI Taisheng
Study of Triptolide Woldifiion T Cell Immune Activation and Inflammation Biomarkers in HIV-infected Immunological Non-responders
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-infected immunological non-responders.
Study Overview
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 given to invention group for 24 weeks.
T cell activation and inflammation biomarkers including CD8+HLA-DR+CD38+, IL-6, D-Dimer and high-sensitivity C-reactive protein (hsCRP), protein degradation-1 (PD-1), Ki67 ,soluble CD14 and CD163, PD-1, CCR5 and CD57 would be tested.
Patients in placebo-controlled group will change to take Triptolide wilfordii (20mg tid po) for another 24 weeks.
All patients will be followed up till 48 weeks.
We hypothesis that Triptolide wilfordii might reduce immune activation and inflammation of HIV immunological non-responders and increase CD4 T cell count, which provides a new strategy for treatment of HIV-infected immunological non-responders.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Wei LU, M.D.
- Phone Number: 00861069155081
- Email: lvweipumch@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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
|
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.
Other Names:
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.
Other Names:
Placebo pills produced the same as Triptolide wilfordii.
Other Names:
|
Experimental: Triptolide + cART
combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of T cell immune activation and inflammation biomarkers
Time Frame: baseline and at 4,8,12,24,36,48 weeks
|
T cell activation and inflammatory biomarkers including CD8+HLA-DR+/CD38+, IL-6, D-dimer and hsCRP,soluble CD14 and CD163, PD-1, CCR5 and CD57 should be measured at baseline and at Wee4, W12, W24, W36, W48 follow-up visits.
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baseline and at 4,8,12,24,36,48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of CD4 T cell count and number of participants with adverse events
Time Frame: baseline and at 4,8,12,24,36,48 weeks
|
Measurement of CD4 T cell count at baseline and different visit points when follow-up and numbers of participants with adverse events.
|
baseline and at 4,8,12,24,36,48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tai sheng LI, M.D., Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
July 1, 2014
Study Completion (Anticipated)
March 1, 2015
Study Registration Dates
First Submitted
March 18, 2013
First Submitted That Met QC Criteria
March 22, 2013
First Posted (Estimate)
March 25, 2013
Study Record Updates
Last Update Posted (Estimate)
March 25, 2013
Last Update Submitted That Met QC Criteria
March 22, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Inflammation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Male
- Antispermatogenic Agents
- Triptolide
Other Study ID Numbers
- CACTRIP12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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