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

Primary Purpose

HIV

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Triptolide
cART
placebo
Sponsored by
LI Taisheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV-infected immunological non-responders, Triptolide, immune activation, inflammation, CD4 T cell

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo + cART

Triptolide + cART

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 18, 2013
Last Updated
March 22, 2013
Sponsor
LI Taisheng
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1. Study Identification

Unique Protocol Identification Number
NCT01817283
Brief Title
Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders
Acronym
CACTrip12
Official Title
Study of Triptolide Woldifiion T Cell Immune Activation and Inflammation Biomarkers in HIV-infected Immunological Non-responders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LI Taisheng

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV-infected immunological non-responders, Triptolide, immune activation, inflammation, CD4 T cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo + cART
Arm Type
Placebo Comparator
Arm 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
Arm Title
Triptolide + cART
Arm Type
Experimental
Arm Description
combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.
Intervention Type
Drug
Intervention Name(s)
Triptolide
Other Intervention Name(s)
Tripterygium Wilfordii Hook F (TwHF)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cART
Other Intervention Name(s)
Antiretroviral therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pills
Intervention Description
Placebo pills produced the same as Triptolide wilfordii.
Primary Outcome Measure Information:
Title
Changes of T cell immune activation and inflammation biomarkers
Description
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.
Time Frame
baseline and at 4,8,12,24,36,48 weeks
Secondary Outcome Measure Information:
Title
Changes of CD4 T cell count and number of participants with adverse events
Description
Measurement of CD4 T cell count at baseline and different visit points when follow-up and numbers of participants with adverse events.
Time Frame
baseline and at 4,8,12,24,36,48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei LU, M.D.
Phone
00861069155081
Email
lvweipumch@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tai sheng LI, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei LU, M.D.
Phone
00861069155081
Email
lvweipumch@163.com

12. IPD Sharing Statement

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

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