Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment - Full Text View

Purpose

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	Intervention	Phase
HIV Infections	Drug: lamivudine, abacavir , ritonavir, atazanavir Drug: emtricitabine, tenofovir, ritonavir, atazanavir	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

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

U.S. FDA Resources

Further study details as provided by International Medical Center of Japan:

Primary Outcome Measures:

antiretroviral effect over 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]


Enrollment:	109
Study Start Date:	October 2007
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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
Study First Received:	October 12, 2007
Last Updated:	March 27, 2015
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by 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

ClinicalTrials.gov processed this record on September 28, 2016