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Researchers to Evaluate a Once-Daily Investigational Dose of Raltegravir, Merck's Integrase Inhibitor, in an Investigational Population, Patients Previously Untreated for HIV-1
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QDMRK Once-Daily Raltegravir Study to be Conducted in 21 Countries Worldwide
WHITEHOUSE STATION, N.J., Oct. 7, 2008 - Merck & Co., Inc. today announced that researchers will conduct a clinical trial to evaluate the use of raltegravir tablets at a once-daily investigational dose in an investigational population, previously untreated (treatment-naive) HIV patients. The once-a-day dose will be compared to a twice-daily regimen, and both will be studied in combination with Truvada (emtricitabine and tenofovir disoproxil fumarate), in treatment-naive HIV patients. The trial, called QDMRK, is a double-blind, randomized, active comparator-controlled clinical trial that aims to enroll 750 patients at 94 centers in 21 countries.
The study will measure the proportion of patients achieving HIV RNA <50 copies/mL at weeks 48 and 96 to determine the antiretroviral activity of raltegravir once daily (raltegravir given 800 mg QD) compared to twice daily (raltegravir 400 mg BID). The study will also evaluate the proportion of patients achieving HIV RNA <400 copies/mL and the change from baseline in CD4 cell counts.
Patients interested in taking part in the QDMRK clinical trial are encouraged to speak with their physician. For more information, please visit www.benchmrk.com and click on QDMRK.
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