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

Sponsor:	International Medical Center of Japan
Collaborator:	Japanese Ministry of Health, Labor and Welfare
Information provided by:	International Medical Center of Japan
ClinicalTrials.gov Identifier:	NCT00544128

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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: AIDS

Drug Information available for: Lamivudine Abacavir Tenofovir Ritonavir Abacavir sulfate BMS 232632 Tenofovir disoproxil Tenofovir Disoproxil Fumarate Atazanavir sulfate Truvada Abacavir-lamivudine combination

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 ]

Estimated Enrollment:	240
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Epzicom Arm: Active Comparator 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
Truvada Arm: Active Comparator 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544128

Contacts

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

Locations

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

Sponsors and Collaborators

International Medical Center of Japan

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Shinichi Oka, MD

International Medical Center of Japan

More Information

No publications provided

Responsible Party:	AIDS Clinical Center, International Medical Center of Japan ( Shinichi Oka, Director general )
Study ID Numbers:	IMCJ-H19-466, ET001
Study First Received:	October 12, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00544128 History of Changes
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:

Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 09, 2009