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Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders (CACTrip12)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Peking Union Medical College
Sponsor:
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT01817283
First received: March 18, 2013
Last updated: March 22, 2013
Last verified: March 2013

March 18, 2013
March 22, 2013
January 2013
July 2014   (final data collection date for primary outcome measure)
Changes of T cell immune activation and inflammation biomarkers [ Time Frame: baseline and at 4,8,12,24,36,48 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01817283 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Measurement of CD4 T cell count at baseline and different visit points when follow-up and numbers of participants with adverse events.
Same as current
Not Provided
Not Provided
 
Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV
  • Drug: 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.
    Other Name: Tripterygium Wilfordii Hook F (TwHF)
  • Drug: 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.
    Other Name: Antiretroviral therapy
  • Drug: placebo
    Placebo pills produced the same as Triptolide wilfordii.
    Other Name: sugar pills
  • 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
    Interventions:
    • Drug: Triptolide
    • Drug: cART
    • Drug: placebo
  • Experimental: Triptolide + cART
    combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.
    Interventions:
    • Drug: Triptolide
    • Drug: cART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Wei LU, M.D. 00861069155081 lvweipumch@163.com
China
 
NCT01817283
CACTRIP12
Yes
LI Taisheng, Peking Union Medical College
LI Taisheng
Not Provided
Principal Investigator: Tai sheng LI, M.D. Peking Union Medical College Hospital
Peking Union Medical College
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP