Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Proof of Concept Study for GSK2248761 (An Extension of NV-05A-002: A Phase I/IIa Double-Blind Study to Evaluate the Safety and Tolerability, Antiretroviral Activity, Pharmacokinetics and Pharmacodynamics of IDX12899 in Antiretroviral Treatment-Naive HIV-1 Infected Subjects, Completed by Idenix)
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.
n/a
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