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

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ClinicalTrials.gov Identifier: NCT00544128

Recruitment Status : Completed

First Posted : October 16, 2007

Last Update Posted : March 30, 2015

Sponsor:

Collaborator:

Ministry of Health, Labour and Welfare, Japan

Information provided by (Responsible Party):

Shinichi Oka, M.D., International Medical Center of Japan

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: lamivudine, abacavir , ritonavir, atazanavir Drug: emtricitabine, tenofovir, ritonavir, atazanavir	Phase 4

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	109 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	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 Start Date :	October 2007
Actual Primary Completion Date :	February 2012
Actual Study Completion Date :	February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Abacavir Emtricitabine Tenofovir Ritonavir Atazanavir Atazanavir sulfate Truvada

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

antiretroviral effect over 48 weeks [ Time Frame: 48 weeks ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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;
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

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): NCT00544128

Locations


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

Sponsors and Collaborators

International Medical Center of Japan

Ministry of Health, Labour and Welfare, Japan

Investigators


Study Chair:	Shinichi Oka, MD	International Medical Center of Japan

More Information

Publications of Results:

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. Epub 2013 Apr 1.


Responsible Party:	Shinichi Oka, M.D., Shinichi Oka, Director general, AIDS Clinical Center, International Medical Center of Japan
ClinicalTrials.gov Identifier:	NCT00544128 History of Changes
Other Study ID Numbers:	IMCJ-H19-466 ET001
First Posted:	October 16, 2007 Key Record Dates
Last Update Posted:	March 30, 2015
Last Verified:	March 2015

Keywords provided by Shinichi Oka, M.D., International Medical Center of Japan:


HIV initial therapy once daily	randomized trial non inferiority Treatment Naive

Additional relevant MeSH terms:


Infection HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate Tenofovir Lamivudine Emtricitabine	Abacavir Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors

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