Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy

This study is not yet open for participant recruitment.
Verified April 2013 by Peking Union Medical College
Sponsor:
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT01844297
First received: August 24, 2012
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive Chinese HIV/AIDS patients.


Condition Intervention
AIDS/HIV PROBLEM
Drug: TDF+3TC+EFV

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Tenofovir Disoproxil Fumarate Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy for ART-naive Chinese Patients With HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College:

Primary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 count at Week 48 [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in CD4 count at Week 96 [ Time Frame: Baseline and 96 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events and laboratory abnormalities from baseline to week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events and laboratory abnormalities from baseline to week 96 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TDF+3TC+EFV Drug: TDF+3TC+EFV

Detailed Description:

This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.

500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 < 250/μL, and by LPV/r when CD4 > 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb < 90/L or neutrophil count < 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.

The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.

  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 of either gender
  • HIV-1 antibody seropositive detected by ELISA and confirmed by western blot
  • CD4 cell count < 500/ul
  • Signed informed consent, with no condition that precludes follow-up for 2 years
  • No plan to move out of the area during the trial
  • antiretroviral therapy naive

Exclusion Criteria:

  • patients in acute phase of HIV infection
  • patients with ongoing opportunistic infection or AIDS-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion
  • patients with the any of the following test results during screening for inclusion:

    • WBC count < 2000/ul,
    • neutrophil count < 1000/ul,
    • Hb < 9g/dl,
    • platelet count < 75000/ul,
    • serum creatinine > 1.5 ULN,
    • transaminases or alkaline phosphatase > 3 ULN,
    • total bilirubin > 2 ULN,
    • serum creatinine kinase > 2 ULN
  • CCr < 60ml/min
  • Pregnancy and breastfeeding
  • Intravenous drug user
  • Severe neuropathy or mental disorder
  • history of alcohol abuse and unable to withdrawal
  • Severe peptic ulcer disease
  • Non-Chinese nationality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01844297

Contacts
Contact: Tai sheng Li, MD 86-10-69155086 litsh@263.net

Locations
China, Beijing
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Contact: Wei Lv, MD    86-10-69155082    lvweipumch@163.com   
Principal Investigator: Taisheng Li, MD         
Sponsors and Collaborators
Peking Union Medical College
  More Information

No publications provided

Responsible Party: LI Taisheng, director of the Department of Infectious Disease, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT01844297     History of Changes
Other Study ID Numbers: CACT1215
Study First Received: August 24, 2012
Last Updated: April 26, 2013
Health Authority: China: Ministry of Science and Technology

Additional relevant MeSH terms:
Lamivudine
Tenofovir
Tenofovir disoproxil
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 17, 2014