Back to resultsComparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
lamivudine, abacavir , ritonavir, atazanavir
emtricitabine, tenofovir, ritonavir, atazanavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, initial therapy, once daily, randomized trial, non inferiority, Treatment Naive
Eligibility Criteria
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;
- alanine aminotransferase is more than 2.5 times higher of upper normal limit
- estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
- 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
Sites / Locations
- International Medical Center of Japan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Epzicom Arm
Truvada Arm
Arm Description
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg
Outcomes
Primary Outcome Measures
antiretroviral effect over 48 weeks
Secondary Outcome Measures
The immunologic effects from baseline at the 48th and 144th week
Reasons of treatment failure by 144th week
Adverse events and their rate of incidence by 144th week
Full Information
NCT ID
NCT00544128
First Posted
October 12, 2007
Last Updated
March 27, 2015
Sponsor
International Medical Center of Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan
1. Study Identification
Unique Protocol Identification Number
NCT00544128
Brief Title
Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Medical Center of Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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;
The immunologic effects from baseline at the 48th and 144th week
Reasons of treatment failure by 144th week
Adverse events and their rate of incidence by 144th week
Serum concentration of tenofovir in selected patients
Serum concentration of atazanavir in selected patients
Renal complication in tenofovir arm
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, initial therapy, once daily, randomized trial, non inferiority, Treatment Naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epzicom Arm
Arm Type
Active Comparator
Arm Description
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
Arm Title
Truvada Arm
Arm Type
Active Comparator
Arm Description
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg
Intervention Type
Drug
Intervention Name(s)
lamivudine, abacavir , ritonavir, atazanavir
Intervention Description
Patients are treated with Epzicom (lamivudine 300mg and abacavir 600mg) combined with ritonavir 100mg boosted atazanavir 300mg
Intervention Type
Drug
Intervention Name(s)
emtricitabine, tenofovir, ritonavir, atazanavir
Intervention Description
Patients are treated with Truvada (emtricitabine 200mg and tenofovir 300mg) combined with ritonavir 100mg boosted atazanavir 300mg.
Primary Outcome Measure Information:
Title
antiretroviral effect over 48 weeks
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
The immunologic effects from baseline at the 48th and 144th week
Time Frame
144 weeks
Title
Reasons of treatment failure by 144th week
Time Frame
144 weeks
Title
Adverse events and their rate of incidence by 144th week
Time Frame
144 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
alanine aminotransferase is more than 2.5 times higher of upper normal limit
estimated glomerular filtration rate is less than 60ml/min by Cockcroft-Gault equation
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinichi Oka, MD
Organizational Affiliation
International Medical Center of Japan
Official's Role
Study Chair
Facility Information:
Facility Name
International Medical Center of Japan
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
1628655
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23545667
Citation
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.
Results Reference
result
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Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
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