drugset / Trial / NCT00615810

ROCKET I - Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial

NCT00615810

Phase 4 Completed 159 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to investigate whether patients switching their backbone from Kivexa to Truvada, who already have raised total cholesterol prior to switching, have an improvement in their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated the study aims to show whether this has a beneficial effect on the patient's overall cardiovascular risk and long term prognosis.

Timeline

Start
2008-03
Primary completion
2009-10
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Atripla Unknown 200 mg Oral
Subject Atripla Unknown 300 mg Oral
Subject Atripla Unknown 600 mg Oral
Comparator Efavirenz Other / unclassified 600 mg Oral
Comparator Raltegravir Other / unclassified 300 mg Oral
Comparator Raltegravir Other / unclassified 600 mg Oral