Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection
- Conditions
- HIV-infection/AIDS
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03403569
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
The traditional Chinese herbal medicine Triptolide Wilfordii has displayed remarkable effect on the treatment of autoimmune diseases such as rheumatoid arthritis. Now that immunosuppression therapy has recently become a new strategy for HIV infection, it's reasonable to expect the anti-inflammatory effect of Triptolide Wilfordii in HIV infected patients. So we designed a randomized, double-blinded, placebo-controlled study to explore the efficacy and safety of Triptolide Wilfordii in new-onset HIV infection.
- Detailed Description
Acquired immune deficiency syndrome(AIDS) is a severe fatal disease caused by HIV infection. Despite viral suppression achieved, antiretroviral therapy(ART) cannot ameliorate HIV-induced immune activation and the consequent non-AIDS complications including cardiovascular, renal, hepatic diseases. Recently, immunosuppression therapy has become the focus since it can suppress exorbitant immune activation and inflammation so as to reduce the risk of non-AIDS cardiovascular and central neural system complications. Triptolide Wilfordii is a traditional Chinese herbal remedy and has long been used in the treatment of autoimmune diseases such as rheumatoid arthritis. Moreover, a recent study has shown that Triptolide Wilfordii combined with ART is associated with increased CD4 T cell counts and reduced immune activation in immunological non-responders, who were defined as patients with CD4 cell counts\<350 cells/ΞΌl despite over 2 years of ART. Hence we expect Triptolide Wilfordii to bring up similar improvement in treatment naΓ―ve HIV infection. This randomized, double-blinded, placebo-controlled study is designed to investigate the safety and efficacy of Triptolide Wilfordii and hopefully provide evidence for a new treatment strategy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 18~65 years old;
- Male or female;
- Good adherence and promise to follow-up;
- Inform Consent signed;
- Positive for HIV antibody test or serum HIV-RNA positive for 2 times or more;
- Present opportunity infection defined according to national AIDS treatment guideline or active opportunistic infection(not stable within 14 days ) within 3 months before recruitment or AIDS-related carcinoma;
- Hemoglobin (HGB) < 9 g/dl, white blood cell (WBC) < 3000/ul, granulin (GRN) < 1500 /ul, platelet (PLT) < 75000 /ul, Cr >1.5x upper limit of normal (ULN), ALT or AST or alkaline phosphatase (ALP) >3x ULN, total bilirubin (TBIL) >2x ULN;
- Pregnancy or breastfeeding;
- Woman with pregnancy plan;
- Severe organ dysfunction;
- Administration of immunosuppressor, immunomodulator(including thymocin) or systemic cytotoxic drugs within 6 months before recruitment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Oral Tablet Group Placebo Oral Tablet 150 patients will be enrolled and be administrated with placebo per os combined with appropriate ART for 12 months. Triptolide Wilfordii Group Triptolide Wilfordii 150 patients will be enrolled and be administrated with Triptolide Wilfordii 20mg three times a day(TID) per os combined with appropriate ART for 12 months.
- Primary Outcome Measures
Name Time Method CD4 T cell counts and HIV RNA Baseline, Week4, Week12, Week24, Week36, Week 48 Compared to patients in placebo group, CD4 T cells of patients treated with Triptolide Wilfordii significantly increase and HIV RNA is reduced below 20 copies/ml.
- Secondary Outcome Measures
Name Time Method HIV reservoir Baseline, Week4, Week12, Week24, Week36, Week 48 Compared to patients in placebo group, HIV reservoir of patients treated with Triptolide Wilfordii is reduced.
Immune activation Baseline, Week4, Week12, Week24, Week36, Week 48 Compared to patients in placebo group, immune activation index of patients treated with Triptolide Wilfordii decreases.
Inflammation level Baseline, Week4, Week12, Week24, Week36, Week 48 Compared to patients in placebo group, inflammation level of patients treated with Triptolide Wilfordii decreases.
Trial Locations
- Locations (7)
The Eighth People's Hospital of Guangzhou
π¨π³Guangzhou, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
π¨π³Harbin, Heilongjiang, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
π¨π³Fuzhou, Fujian, China
The Sixth People's Hospital of Zhengzhou
π¨π³Zhengzhou, Henan, China
Xixi Hospital of Hangzhou
π¨π³Hangzhou, Zhejiang, China
Beijing Ditan Hospital, Capital Medical University
π¨π³Beijing, China
Beijing YouAn Hospital, Capital Medical University
π¨π³Beijing, China