KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

Summary

This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

Timeline

Start

2004-05

Primary completion

—

Completion

—

Outcome

Met primary endpoint

release “HIV regimens using LEXIVA (Telzir) Tablets+ritonavir and Kaletra (lopinavir/ritonavir) Capsules both given twice-daily had comparable (non-inferior) efficacy and tolerability” vrtx.com ↗

release “Lexiva appears to be comparable to Kaletra and has met the primary endpoints” vrtx.com ↗

release “had comparable (non-inferior) efficacy and tolerability to lopinavir/r twice daily in treatment-naive adults” vrtx.com ↗

Publications

• Background Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. doi: 10.1016/S0140-6736(06)69155-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fosamprenavir	Small molecule	700 mg	—
Subject	Lopinavir	Other / unclassified	400 mg	—
Background	Abacavir	Other / unclassified	600 mg	—
Background	Lamivudine	Other / unclassified	300 mg	—
Background	Ritonavir	Other / unclassified	100 mg	—

Indications