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

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ClinicalTrials.gov Identifier: NCT01844297
Recruitment Status : Unknown
Verified April 2013 by LI Taisheng, Peking Union Medical College.
Recruitment status was:  Not yet recruiting
First Posted : May 1, 2013
Last Update Posted : May 1, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
AIDS/HIV PROBLEM 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
TDF+3TC+EFV Drug: TDF+3TC+EFV


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 [ Time Frame: 96 weeks ]
  2. Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96 [ Time Frame: 96 weeks ]
  3. Change From Baseline in CD4 count at Week 48 [ Time Frame: Baseline and 48 weeks ]
  4. Change From Baseline in CD4 count at Week 96 [ Time Frame: Baseline and 96 weeks ]
  5. Incidence of adverse events and laboratory abnormalities from baseline to week 48 [ Time Frame: 48 weeks ]
  6. Incidence of adverse events and laboratory abnormalities from baseline to week 96 [ Time Frame: 96 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Tenofovir
Lamivudine
Efavirenz
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers