Clinical trial NCT03403569: Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection
Official title: Impact of Triptolide Wilfordii on Viral Suppression, Immune Recovery and Immune Activation Biomarkers in Treatment-naive HIV-1 Infection: a Randomized, Double-blinded, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-infection/AIDS
Keywords: CD4 cell recovery
immune activation
anti-inflammation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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/μl despite over 2 years of ART. Hence we expect Triptolide Wilfordii to bring up similar improvement in treatment naïve 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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: CD4 T cell counts and HIV RNA
timeFrame: Baseline, Week4, Week12, Week24, Week36, Week 48
Secondary outcomes:
measure: Immune activation
timeFrame: Baseline, Week4, Week12, Week24, Week36, Week 48
measure: Inflammation level
timeFrame: Baseline, Week4, Week12, Week24, Week36, Week 48
measure: HIV reservoir
timeFrame: Baseline, Week4, Week12, Week24, Week36, Week 48
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The Eighth People's Hospital of Guangzhou
state: Guangdong
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Sixth People's Hospital of Zhengzhou
state: Henan
city: Hangzhou
country: China
facility: Xixi Hospital of Hangzhou
state: Zhejiang
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
Study officials:
affiliation: Department of Infectious Diseases, PekingUMCH
name: Wei Lyu
role: PRINCIPAL_INVESTIGATOR
References: