Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults.

Summary

GSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty treatment-naïve subjects infected with HIV-1. GSK2248761 doses sequentially evaluated were 800 mg QD, 400 mg QD, 200 mg QD and 100mg QD. This study will evaluate a lower dose, or doses, of GSK2248761 to better characterize the dose-response and concentration-response curves. The results from this study will be used to select doses for future clinical studies in HIV-1 infected subjects.

Timeline

Start

2009-10-20

Primary completion

2009-11-28

Completion

2009-11-28

Outcome

Mixed primary results

registry analysis (superiority test); GSK2248761 30 mg vs Placebo; p = 0.042 NCT00945282 ↗

registry analysis (superiority test); GSK2248761 30 mg vs Placebo; p = 0.221 NCT00945282 ↗

Publications

• Background Zala C, St Clair M, Dudas K, Kim J, Lou Y, White S, Piscitelli S, Dumont E, Pietropaolo K, Zhou XJ, Mayers D. Safety and efficacy of GSK2248761, a next-generation nonnucleoside reverse transcriptase inhibitor, in treatment-naive HIV-1-infected subjects. Antimicrob Agents Chemother. 2012 May;56(5):2570-5. doi: 10.1128/AAC.05597-11. Epub 2012 Feb 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FOSDEVIRINE	Small molecule	10 mg	—
Subject	FOSDEVIRINE	Small molecule	20 mg	—
Subject	FOSDEVIRINE	Small molecule	30 mg	—
Subject	FOSDEVIRINE	Small molecule	40 mg	—
Subject	FOSDEVIRINE	Small molecule	90 mg	—
Background	Lopinavir	Other / unclassified	400 mg	—
Background	Ritonavir	Other / unclassified	100 mg	—

Indications