Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing @entity486 -boosted @entity5194 to efavirenz with fixed-dose @entity22208 and XXXX .

@entity1 @entity5194 @entity16332 @entity26548 @entity22208 @entity645 @entity11254 @entity56 @entity486 @entity791 @entity65 @entity165
BACKGROUND: The side-effects of anti-retroviral drugs are different between Japanese and Caucasian @entity1 . Severe central nerve system (CNS) side-effects to efavirenz and low rate of @entity56 against @entity22208 characterize the Japanese. OBJECTIVE: The objective of this study was to select a once daily regimen for further non-inferior study comparing the virological efficacy and safety of the first line once daily antiretroviral treatment regimens in the current @entity645 / @entity791 guideline. METHODS: The study design was a randomized, open label, multicenter, selection study. One arm was treated with efavirenz and the other with @entity486 -boosted @entity5194 . A fixed-dose @entity16332 plus @entity22208 were used in both arms. The primary endpoint was virologic success (viral load less than 50 copies/mL) rate at 48 weeks. @entity1 were followed-up to 96 weeks with safety as the secondary endpoint. Clinicaltrials. @entity26548 (NCT00280969) and the University hospital Medical Information Network (UMIN000000243). RESULTS: A total of 71 @entity1 were enrolled. Virologic success rates in both arms were similar at week 48 [efavirenz arm 28/36 (77.8%); @entity5194 arm 27/35 (77.1%)], but were decreased at week 96 to 55.6% in the efavirenz arm and 68.8% in the @entity5194 arm (p=0.33). At the 96-week follow-up, 52.8% of the EFV arm and 34.3% of the @entity11254 /r arm reached total @entity165 more than 220 mg/dL and required treatment. None of the @entity1 developed @entity65 in this study by week 96. CONCLUSION: There was no significant difference in the efficacy of efavirenz and @entity486 -boosted @entity5194 combined with @entity16332 plus @entity22208 at 48 weeks. The evaluation of safety was extended to 96 weeks, which also showed no significant difference in both arms.
