Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection

Study Overview
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Brief Summary
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This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii on HIV-1 reservoir.

Detailed Description
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Two arms will be enrolled in this study, 18 naive-treatment Chinese patients in acute HIV-1 infection phase would be allocated to two arms, and treated with the antiretroviral drugs (Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir). Six months later, 12 patients will be treated with Triplitode, in order to observe the impact of of Triptolide wilfordii on HIV-1 reservoir of patients in acute infection phase. All patients should be explored for 18 months in terms of the clinical features, drugs side-effects, and immunological and viral response, and the HIV-1 reservoir. We hypothesis that Triptolide wilfordii might further reduce the HIV-1 reservoir. The result would provide proofs for further practical antiviral therapy for patients in acute infection phase in China or other resource limited countries.

Official Title
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Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection

Conditions
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AIDS/HIV PROBLEM

Intervention / Treatment
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* Drug: Triplitode
* Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • age between 18-65 years HIV seropositive and confirmed by western blot, confirmed as acute HIV-1 infection good adherence and follow up in the same place Inform Consent signed ART-naïve Exclusion Criteria: Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma; hemoglobin (HGB) < 9 g/dl 、 white blood cell (WBC) < 2000/ul 、 granulin (GRN) < 1000 /ul 、 platelet (PLT) < 75000 /ul 、 Cr >1.5x ULN 、 ALT or AST or alkaline phosphatase (ALP) >3x upper limit of normal (ULN) 、 total bilirubin (TBIL) >2x ULN 、 creatine kinase (CK) > 2x ULN; Pregnant or breastfeeding woman or woman with pregnancy plan; Active drug-user;Severe neurological defects; Active alcohol abuse; Severe gastrointestinal ulcer . End-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc Those who are undertaking steroids, immunomodulator, anti-inflammatory agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triptolide group<br>cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months | Drug: Triplitode<br>* Drug: Triptolide Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular. Other Name: Tripterygium Wilfordii Hook F (TwHF) Drug: cART Participants who will be enrolled in this Triplitode group would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir .<br>* Other names: Triptolide Wilfordii;|
| Active Comparator: Comparator group<br>combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months | Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir<br>* Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.<br>* Other names: TDF+3TC+LPV/r+RAL for 18 months;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the immunologic response, virologic response, and hiv-1 reservoir |  | baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of the therapy |  | thirty-six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triptolide wilfordii HIV-1 reservoir acute hiv infection