Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection

HIV-infection/AIDS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403569
• Other study ID #: PekingUMCH record JS-985
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• HIV-infection/AIDS
• Infections

Intervention

Drug:
• Triptolide Wilfordii
In addition to appropriate ART, Triptolide Wilfordii will be given to patients in the experimental group at a dosage of 20mg three times a day per os for 12 months.
• Placebo Oral Tablet
In addition to appropriate ART, placebo oral tablets will be given to patients in the experimental group at a dosage of 2 pills three times a day per os for 12 months.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital, Capital Medical University	Beijing
China	Beijing YouAn Hospital, Capital Medical University	Beijing
China	Mengchao Hepatobiliary Hospital of Fujian Medical University	Fuzhou	Fujian
China	The Eighth People's Hospital of Guangzhou	Guangzhou	Guangdong
China	Xixi Hospital of Hangzhou	Hangzhou	Zhejiang
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Sixth People's Hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 T cell counts and HIV RNA	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.	Baseline, Week4, Week12, Week24, Week36, Week 48
Secondary	Immune activation	Compared to patients in placebo group, immune activation index of patients treated with Triptolide Wilfordii decreases.	Baseline, Week4, Week12, Week24, Week36, Week 48
Secondary	Inflammation level	Compared to patients in placebo group, inflammation level of patients treated with Triptolide Wilfordii decreases.	Baseline, Week4, Week12, Week24, Week36, Week 48
Secondary	HIV reservoir	Compared to patients in placebo group, HIV reservoir of patients treated with Triptolide Wilfordii is reduced.	Baseline, Week4, Week12, Week24, Week36, Week 48