Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders (CACTrip12)
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ClinicalTrials.gov Identifier: NCT01817283 |
Recruitment Status
: Unknown
Verified March 2013 by LI Taisheng, Peking Union Medical College.
Recruitment status was: Recruiting
First Posted
: March 25, 2013
Last Update Posted
: March 25, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Triptolide Drug: cART Drug: placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Study of Triptolide Woldifiion T Cell Immune Activation and Inflammation Biomarkers in HIV-infected Immunological Non-responders |
Study Start Date : | January 2013 |
Estimated Primary Completion Date : | July 2014 |
Estimated Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
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
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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
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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
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- Changes of T cell immune activation and inflammation biomarkers [ Time Frame: baseline and at 4,8,12,24,36,48 weeks ]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.
- 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 ]Measurement of CD4 T cell count at baseline and different visit points when follow-up and numbers of participants with adverse events.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817283
Contact: Wei LU, M.D. | 00861069155081 | lvweipumch@163.com |
China | |
Peking Union Medical College Hospital | Recruiting |
Beijing, China, 100730 | |
Contact: Wei LU, M.D. 00861069155081 lvweipumch@163.com |
Principal Investigator: | Tai sheng LI, M.D. | Peking Union Medical College Hospital |
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 |
First Posted: | March 25, 2013 Key Record Dates |
Last Update Posted: | March 25, 2013 |
Last Verified: | March 2013 |
Keywords provided by LI Taisheng, Peking Union Medical College:
HIV-infected immunological non-responders Triptolide immune activation inflammation CD4 T cell |
Additional relevant MeSH terms:
Inflammation Pathologic Processes Triptolide Antispermatogenic Agents Physiological Effects of Drugs Contraceptive Agents, Male Contraceptive Agents |
Reproductive Control Agents Immunosuppressive Agents Immunologic Factors Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |