Comparison of Epzicom and Truvada for the Initial Once Daily HIV Treatment
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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) |
- antiretroviral effect over 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- 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 |
---|---|
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
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
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
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 |
Japan | |
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 |
Study Chair: | Shinichi Oka, MD | International Medical Center of Japan |
No publications provided
Responsible Party: | 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: | February 6, 2009 |
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:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lamivudine Tenofovir Tenofovir disoproxil Abacavir |
Ritonavir Atazanavir Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on October 17, 2012