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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2013 by Peking Union Medical College.
Recruitment status was Recruiting

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

History of Changes

Purpose

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.

Condition	Intervention	Phase
HIV	Drug: Triptolide Drug: cART Drug: placebo	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Study of Triptolide Woldifiion T Cell Immune Activation and Inflammation Biomarkers in HIV-infected Immunological Non-responders

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Peking Union Medical College:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Estimated Enrollment:	150
Study Start Date:	January 2013
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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
Experimental: Triptolide + cART combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.	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

Arms

Assigned Interventions

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

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

Experimental: Triptolide + cART

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

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

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


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817283

Contacts


Contact: Wei LU, M.D.	00861069155081	lvweipumch@163.com

Locations


China
Peking Union Medical College Hospital	Recruiting
Beijing, China, 100730
Contact: Wei LU, M.D. 00861069155081 lvweipumch@163.com

Sponsors and Collaborators

LI Taisheng

Investigators


Principal Investigator:	Tai sheng LI, M.D.	Peking Union Medical College Hospital

More Information

No publications provided


Responsible Party:	LI Taisheng, Peking Union Medical College Hospital, Peking Union Medical College
ClinicalTrials.gov Identifier:	NCT01817283 History of Changes
Other Study ID Numbers:	CACTRIP12
Study First Received:	March 18, 2013
Last Updated:	March 22, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by Peking Union Medical College:


HIV-infected immunological non-responders Triptolide immune activation inflammation CD4 T cell

Additional relevant MeSH terms:


Triptolide Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Antispermatogenic Agents Contraceptive Agents Contraceptive Agents, Male	Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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