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

LI Taisheng

Status and phase: Unknown; Phase 2; Phase 1

Conditions: HIV

Treatments: Drug: cART; Drug: Triptolide; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01817283

CACTRIP12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

placebo + cART

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Drug: Triptolide

Drug: cART

Triptolide + cART

Experimental group

Description:

combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.

Treatment:

Drug: Triptolide

Drug: cART