Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by International Medical Center of Japan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
International Medical Center of Japan
ClinicalTrials.gov Identifier:
NCT00544128
First received: October 12, 2007
Last updated: February 6, 2009
Last verified: February 2009

October 12, 2007
February 6, 2009
October 2007
March 2011   (final data collection date for primary outcome measure)
antiretroviral effect over 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
antiretroviral effect over 48 weeks [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00544128 on ClinicalTrials.gov Archive Site
  • The immunologic effects from baseline at the 48th and 144th week [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Reasons of treatment failure by 144th week [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events and their rate of incidence by 144th week [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
  • The immunologic effects from baseline at the 48th and 144th week [ Time Frame: 144 weeks ]
  • Reasons of treatment failure by 144th week [ Time Frame: 144 weeks ]
  • Adverse events and their rate of incidence by 144th week [ Time Frame: 144 weeks ]
Not Provided
Not Provided
 
Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study)

A non-inferiority randomized control trial in treatment naïve HIV patients to compare virologic effect of two backbone regimens with Epzicom (lamivudine and abacavir) and Truvada (emtricitabine and tenofovir). Both arms are treated with fixed combination of ritonavir boosted atazanavir as key drugs.

In treatment naïve HIV-1-infected patients, once daily combination antiretroviral therapy containing ritonavir boosted atazanavir combined with Epzicom will offer non inferior antiretroviral efficacy compared to ritonavir boosted atazanavir combined with Truvada. This non inferiority hypothesis is studied by a randomized, open label, multicenter trial over 48 weeks as the primary endpoint and long term safety of both arms are followed for 144 weeks.

The primary endpoint is the antiretroviral effect over 48 weeks.

The secondary endpoints are;

  1. The immunologic effects from baseline at the 48th and 144th week
  2. Reasons of treatment failure by 144th week
  3. Adverse events and their rate of incidence by 144th week
  4. Serum concentration of tenofovir in selected patients
  5. Serum concentration of atazanavir in selected patients
  6. Renal complication in tenofovir arm
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: lamivudine, abacavir , ritonavir, atazanavir
    Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
  • Drug: emtricitabine, tenofovir, ritonavir, atazanavir
    Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.
  • Active Comparator: Epzicom Arm
    Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
    Intervention: Drug: lamivudine, abacavir , ritonavir, atazanavir
  • Active Comparator: Truvada Arm
    Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg
    Intervention: Drug: emtricitabine, tenofovir, ritonavir, atazanavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
March 2013
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of HIV infection,
  • Antiretroviral initiation is recommended by current clinical guidelines,
  • Treatment naïve,
  • Age over 20 years old Japanese,
  • Able to obtain written informed consent

Exclusion Criteria:

  • Current malabsorption condition,
  • Prior use of lamivudine for hepatitis B treatment,
  • Positive serology of Hepatitis B surface antigen,
  • Patients who have following abnormal laboratory results within 6 weeks prior enrollment;

    1. alanine aminotransferase is more than 2.5 times higher of upper normal limit
    2. estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
    3. serum phosphate level is less than 2.0mg/dl
  • Patients with hemophilia, diabetes mellitus which require pharmacological treatment, congestive heart failure, cardiomyopathy or other serious medical condition
  • Patients in pregnancy or breat feeding
  • Patients who are taking medications contraindicated combine use of study medicine
  • Patients whose primary care physicians consider inadequate to be enroll the study
Both
20 Years and older
No
Contact: Shinichi Oka, MD +81-3-5273-5193 oka@imcj.hosp.go.jp
Contact: Miwako Honda, MD +81-3-3202-7181 ext 5639 mihonda@imcj.acc.go.jp
Japan
 
NCT00544128
IMCJ-H19-466, ET001
Yes
Shinichi Oka, Director general, AIDS Clinical Center, International Medical Center of Japan
International Medical Center of Japan
Ministry of Health, Labour and Welfare, Japan
Study Chair: Shinichi Oka, MD International Medical Center of Japan
International Medical Center of Japan
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP