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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 3

Conditions: HIV-infection/AIDS

Treatments: Drug: Triptolide Wilfordii; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03403569

PekingUMCH record JS-985

Details and patient eligibility

About

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.

Full 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.

Enrollment: 353 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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353 participants in 2 patient groups, including a placebo group

Triptolide Wilfordii Group

Experimental group

Description:

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.

Treatment:

Drug: Triptolide Wilfordii

Placebo Oral Tablet Group

Placebo Comparator group

Description:

150 patients will be enrolled and be administrated with placebo per os combined with appropriate ART for 12 months.

Treatment:

Drug: Placebo Oral Tablet