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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV-infection/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Triptolide Wilfordii Group

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.

Group Type EXPERIMENTAL

Triptolide Wilfordii

Intervention Type DRUG

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 Group

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No