Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV

Phase 4 Completed 688 enrolled GlaxoSmithKline

RandomizedParallel-groupDouble-blindTreatment

Summary

This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks

Timeline

Start: 2005-07
Primary completion: 2008-04
Completion: 2008-04

Outcome

Met primary endpoint

paper demonstrating the noninferiority of ABC/3TC to TDF/FTC at week 48. PMID 19542866 ↗

Publications

Smith KY, Patel P, Fine D, Bellos N, Sloan L, Lackey P, Kumar PN, Sutherland-Phillips DH, Vavro C, Yau L, Wannamaker P, Shaefer MS; HEAT Study Team. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS. 2009 Jul 31;23(12):1547-56. doi: 10.1097/QAD.0b013e32832cbcc2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abacavir	Other / unclassified	600 mg	—
Subject	Lamivudine	Other / unclassified	300 mg	—
Comparator	Tenofovir	Small molecule	300 mg	—
Comparator	emtricitabine	Other / unclassified	200 mg	—
Comparator	Lopinavir	Other / unclassified	800 mg	—
Comparator	Ritonavir	Other / unclassified	200 mg	—