HIV
Conditions
Keywords
HIV-infected immunological non-responders, Triptolide, immune activation, inflammation, CD4 T cell
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.
Interventions
DRUGTriptolide
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.
DRUGcART
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.
DRUGplacebo
Placebo pills produced the same as Triptolide wilfordii.
Sponsors
LI Taisheng
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of T cell immune activation and inflammation biomarkers | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of CD4 T cell count and number of participants with adverse events | 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. |
Countries
China
Contacts
Primary ContactWei LU, M.D.
Outcome results
None listed