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 Infectio
- Conditions
- HIV
- Registration Number
- JPRN-UMIN000000849
- Lead Sponsor
- International Medical Center of Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 240
Not provided
-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 aminotransferaseis 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, breast feeding, -Patients who are taking medicaitions contraindicated for combine use with study medicine -Patients whose primary care physicians consider inadequate to be enrolled
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method antiretroviral effect over 48 weeks
- Secondary Outcome Measures
Name Time Method 1)The immunological effects from baseline at the 48th and 144th week 2)Reasons of treatment failure by 144th week 3)Adverse events and their rate of incidence by 144th week 4)Serum concentration of tenofovir in selected patients 5)Serum concentration of atazanavir in selected patients 6)Renal complication in tenofovir arm