ROCKET II - Randomized Open Label Switch for Cholesterol Elevation on Kivexa + Kaletra Evaluation Trial

Phase 4 Completed 85 enrolled Gilead Sciences

RandomizedParallel-groupOpen-labelTreatment

Summary

This study investigated whether human immunodeficiency virus type 1 (HIV-1) infected subjects with raised cholesterol switching their nucleoside reverse transcriptase inhibitor (NRTI) backbone from Kivexa (Epzicom) to Truvada had an improvement in their fasting total cholesterol after 12 weeks of treatment. The study also investigated whether any improvement had a beneficial effect on the overall cardiovascular risk.

Timeline

Start: 2008-10
Primary completion: 2009-09
Completion: 2009-10

Publications

Behrens G, Maserati R, Rieger A, Domingo P, Abel F, Wang H, Pearce G. Switching to tenofovir/emtricitabine from abacavir/lamivudine in HIV-infected adults with raised cholesterol: effect on lipid profiles. Antivir Ther. 2012;17(6):1011-20. doi: 10.3851/IMP2305. Epub 2012 Aug 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Abacavir	Other / unclassified	600 mg	Oral
Comparator	Lamivudine	Other / unclassified	300 mg	Oral
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Subject	emtricitabine	Other / unclassified	200 mg	Oral
Background	Lopinavir	Other / unclassified	200 mg	Oral
Background	Ritonavir	Other / unclassified	50 mg	Oral

Indications

No indication recorded.