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

Phase 3

• Conditions: AIDS/HIV PROBLEM
• Interventions: Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir; Drug: Triplitode

• Registration Number: NCT02219672
• Lead Sponsor: Peking Union Medical College

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2014-08
• Study First Submitted: 2014-08-16
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-19
• Last Update Posted: 2014-08-19
• Primary Completion: 2016-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Comparator group	Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir	combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months
Triptolide group	Triplitode	cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events of the therapy	thirty-six months

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China