Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.

Phase 2 Completed 278 enrolled Gilead Sciences

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.

Timeline

Start: 2006-02
Primary completion: 2007-06
Completion: 2007-07

Outcome

Met primary endpoint

paper the elvitegravir 50 mg arm was noninferior (-1.44 log(10) copies/mL) PMID 20146631 ↗

paper the elvitegravir 125 mg arm was superior (-1.66 log(10) copies/mL; P = .021). PMID 20146631 ↗

release “24-week Phase II dose-ranging trial of GS 9137 (elvitegravir) and stated that the clinical study met its primary endpoint” gilead.com ↗

Publications

Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, Kearney BP, Cheng AK. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis. 2010 Mar 15;201(6):814-22. doi: 10.1086/650698.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	elvitegravir	Small molecule	20 mg	—
Subject	elvitegravir	Small molecule	50 mg	—
Subject	elvitegravir	Small molecule	125 mg	—