drugset / Trial / NCT00615745

ONCE - Only Nocturnal Combination Evaluation of Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla

NCT00615745

Phase 4 Completed 115 enrolled Gilead Sciences
NaSingle-groupOpen-labelTreatment

Summary

A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day. The individual components of this HAART regimen have demonstrated efficacy and safety in HIV treatment-naive patients and offer simplification that in turn may increase adherence and improve clinical outcomes. This study aims to evaluate the effectiveness (efficacy, safety and tolerability) of a STR simplification strategy in patients on HAART who have achieved viral suppression in a real world clinical setting.

Timeline

Start
2008-04
Primary completion
2010-11
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Efavirenz Other / unclassified 600 mg Oral
Subject Tenofovir disoproxil fumarate Small molecule 300 mg Oral
Subject emtricitabine Other / unclassified 200 mg Oral