A Phase 1/2 interventional study of Triptolide and cART in HIV, sponsored by LI Taisheng. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-03-25.
Sponsored by LI Taisheng · Phase 1/2, Interventional, and Treatment
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.
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.
3,513 studies on the registry are indexed under Inflammation; 641 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 2,491 interventional studies indexed under Inflammation.
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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 · Drug: cART · Drug: placebo
combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.
Drug: Triptolide · Drug: cART
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.
Also known as: Tripterygium Wilfordii Hook F (TwHF)
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.
Also known as: Antiretroviral therapy
Placebo pills produced the same as Triptolide wilfordii.
Also known as: sugar pills
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.
Time frame: baseline and at 4,8,12,24,36,48 weeks
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.
Time frame: baseline and at 4,8,12,24,36,48 weeks
The record gives a start of Jan 2013, a primary completion of Jul 2014 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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LI Taisheng