Gilead Sciences announced that it has begun enrolling patients in a Phase II clinical trial of its investigational integrase-based, single-tablet, once-daily regimen of elvitegravir, GS 9350 and Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection. The Phase II study is a randomized, double-blind, 48-week clinical trial that will evaluate the safety and efficacy of a single-tablet containing elvitegravir, GS 9350 and Truvada versus Atripla, each administered in HIV-infected treatment-naïve adults with HIV RNA levels (viral load) greater than or equal to 5,000 copies/mL and CD4 cell counts greater than 50 cells/mm3. The study will enroll 75 HIV-1 infected, antiretroviral treatment-naïve adults across approximately 50 investigative sites in the United States.  The primary endpoint will be the proportion of patients with viral loads less than 50 copies/mL at 24 weeks of treatment. Secondary endpoints will include the proportion of patients with viral loads less than 50 copies/mL at 48 weeks of treatment, and the safety and tolerability of the two treatment regimens through 48 weeks of treatment.

GS 9350 is an investigational compound being developed as a pharmacoenhancing or “boosting” agent to increase blood levels and allow once-daily dosing for certain medicines, including Gilead’s investigational HIV integrase inhibitor, elvitegravir.

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