A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

Phase 3 Completed 211 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.

Timeline

Start: 2006-05
Primary completion: 2008-06
Completion: 2008-06

Outcome

Met primary endpoint

paper the 2 regimens met prespecified noninferiority criteria (FPV/r100, 92%; FPV/r 200, 94%; 95% CI, -9.36 to 5.12). PMID 21126954 ↗

Publications

Cohen C, Dejesus E, Lamarca A, Young B, Yau L, Patel L, Vavro C, Wire MB, Wannamaker P, Shaefer M. Similar virologic and immunologic efficacy with fosamprenavir boosted with 100 mg or 200 mg of ritonavir in HIV-infected patients: results of the LESS trial. HIV Clin Trials. 2010 Sep-Oct;11(5):239-47. doi: 10.1310/hct1105-239.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fosamprenavir	Small molecule	700 mg	—
Subject	Fosamprenavir	Small molecule	1400 mg	—
Subject	Ritonavir	Other / unclassified	100 mg	—
Subject	Ritonavir	Other / unclassified	200 mg	—