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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Medical Center of Japan
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Abacavir; Atazanavir Sulfate; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Ritonavir; Tenofovir

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