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

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

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.

Study Overview

• Status: Unknown
• Conditions: AIDS/HIV PROBLEM
• Intervention / Treatment: Drug: Triplitode; Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir

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 Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Principal Investigator: Taisheng Li, PhD
      • Contact: Fuping Guo, MD; Phone Number: 86-10-69155082; Email: pumchguofp@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triptolide group; cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months	Drug: Triplitode; 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 .; Other Names: Triptolide Wilfordii
Active Comparator: Comparator group; combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months	Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir; Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.; Other Names: TDF+3TC+LPV/r+RAL for 18 months

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College
• Collaborators: Ministry of Science and Technology of the People´s Republic of China
• Investigators: Principal Investigator: Taisheng Li, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: August 16, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (Estimate): August 19, 2014

Study Record Updates

• Last Update Posted (Estimate): August 19, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Triptolide wilfordii HIV-1 reservoir acute hiv infection
• Additional Relevant MeSH Terms: Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protease Inhibitors; Antineoplastic Agents, Alkylating; Alkylating Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Contraceptive Agents; Reproductive Control Agents; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Contraceptive Agents, Male; Antispermatogenic Agents; Tenofovir; Raltegravir Potassium; Ritonavir; Lopinavir; Lamivudine; Triptolide
• Other Study ID Numbers: CACT140816