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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Peking Union Medical College
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT02219672
First received: August 16, 2014
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
AIDS/HIV PROBLEM
Drug: Triplitode
Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College:

Primary Outcome Measures:
  • Changes of the immunologic response, virologic response, and hiv-1 reservoir [ Time Frame: baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events of the therapy [ Time Frame: thirty-six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: July 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TDF+3TC+LPV/r+RAL for 18 months

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02219672

Contacts
Contact: Wei Lv, MD 8610-69155046 lvweipumch@163.com
Contact: Fuping Guo, MD 8610-69155046 pumchguofp@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Fuping Guo, MD    86-10-69155082    pumchguofp@163.com   
Principal Investigator: Taisheng Li, PhD         
Sponsors and Collaborators
Peking Union Medical College
Ministry of Science and Technology of the People´s Republic of China
Investigators
Principal Investigator: Taisheng Li, PhD Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: LI Taisheng, department of the infectious disease, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT02219672     History of Changes
Other Study ID Numbers: CACT140816
Study First Received: August 16, 2014
Last Updated: August 18, 2014
Health Authority: China: Ministry of Science and Technology

Keywords provided by Peking Union Medical College:
Triptolide wilfordii HIV-1 reservoir acute hiv infection

Additional relevant MeSH terms:
Infection
Ritonavir
Lopinavir
Tenofovir
Tenofovir disoproxil
Lamivudine
Triptolide
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Antispermatogenic Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014