Clinical trial NCT01817283: Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders
Official title: Study of Triptolide Woldifiion T Cell Immune Activation and Inflammation Biomarkers in HIV-infected Immunological Non-responders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: HIV
Keywords: HIV-infected immunological non-responders
Triptolide
immune activation
inflammation
CD4 T cell
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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-infected immunological non-responders.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of T cell immune activation and inflammation biomarkers
timeFrame: baseline and at 4,8,12,24,36,48 weeks
Secondary outcomes:
measure: Changes of CD4 T cell count and number of participants with adverse events
timeFrame: baseline and at 4,8,12,24,36,48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Tai sheng LI, M.D.
role: PRINCIPAL_INVESTIGATOR
References: