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

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.
|
- antiretroviral effect over 48 weeks [ Time Frame: 48 weeks ]
- 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 ]

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

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
Japan | |
International Medical Center of Japan | |
Shinjuku, Tokyo, Japan, 1628655 |
Study Chair: | Shinichi Oka, MD | International Medical Center of Japan |
Publications of Results:
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 |