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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: lamivudine, abacavir , ritonavir, atazanavir; Drug: emtricitabine, tenofovir, ritonavir, atazanavir

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Shinjuku, Tokyo, Japan, 1628655
      • International Medical Center of Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epzicom Arm; Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg	Drug: lamivudine, abacavir , ritonavir, atazanavir; Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
Active Comparator: Truvada Arm; Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
antiretroviral effect over 48 weeks	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The immunologic effects from baseline at the 48th and 144th week	144 weeks
Reasons of treatment failure by 144th week	144 weeks
Adverse events and their rate of incidence by 144th week	144 weeks

Collaborators and Investigators

• Sponsor: International Medical Center of Japan
• Collaborators: Ministry of Health, Labour and Welfare, Japan
• Investigators: Study Chair: Shinichi Oka, MD, International Medical Center of Japan

Publications and helpful links

General Publications

• Nishijima T, Takano M, Ishisaka M, Komatsu H, Gatanaga H, Kikuchi Y, Endo T, Horiba M, Kaneda S, Uchiumi H, Koibuchi T, Naito T, Yoshida M, Tachikawa N, Ueda M, Yokomaku Y, Fujii T, Higasa S, Takada K, Yamamoto M, Matsushita S, Tateyama M, Tanabe Y, Mitsuya H, Oka S; Epzicom-Truvada study team. Abacavir/lamivudine versus tenofovir/emtricitabine with atazanavir/ritonavir for treatment-naive Japanese patients with HIV-1 infection: a randomized multicenter trial. Intern Med. 2013;52(7):735-44. doi: 10.2169/internalmedicine.52.9155. Epub 2013 Apr 1.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 12, 2007
• First Submitted That Met QC Criteria: October 15, 2007
• First Posted (Estimate): October 16, 2007

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: HIV; randomized trial; Treatment Naive; non inferiority; once daily; initial therapy
• Additional Relevant MeSH Terms: Infections; 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; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Tenofovir; Emtricitabine; Ritonavir; Lamivudine; Atazanavir Sulfate; Abacavir
• Other Study ID Numbers: IMCJ-H19-466; ET001