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

HIV Clinical Trial

— CACTrip12  

Official title:

Study of Triptolide Woldifiion T Cell Immune Activation and Inflammation Biomarkers in HIV-infected Immunological Non-responders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01817283
• Other study ID #: CACTRIP12
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 18, 2013
• Last updated: March 22, 2013
• Start date: January 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2013
• Source: Peking Union Medical College
• Contact: Wei LU, M.D.
• Phone: 00861069155081
• Email: lvweipumch[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Inflammation

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
LI Taisheng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of T cell immune activation and inflammation biomarkers	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.	baseline and at 4,8,12,24,36,48 weeks	No
Secondary	Changes of CD4 T cell count and number of participants with adverse events	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	Yes