Likewise, Grade 3-4 lab abnormalities were similar between all three treatment arms, and all regimens had minimal impact on plasma lipids. The incidence of Grade 3-4 lipid abnormalities was low. No subject experienced a Grade 3-4 elevation in cholesterol, whereas elevated triglyceride levels occurred in 8 percent of patients taking 908/r BID (n=8,) versus 4 percent of patients taking 908/r QD (n=4) or LPV/r BID (n=4). Mean fasting cholesterol levels for all three study groups remained below the recommended National Cholesterol Education Program (NCEP) intervention guidelines.
The study population comprised patients enrolled from 103 centers in 13 countries worldwide. Approximately 16 percent of patients enrolled in CONTEXT are female, and the age range of all patients is 24 72 years (median 41 years). Sixty-seven percent of patients are Caucasian, 24 percent are of African descent and 9 percent are Hispanic. Criteria for entry into the study included treatment-experienced patients with current failure of antiretroviral therapy. To enroll in the CONTEXT trial, patients had to have a screening viral load >1,000 copies/mL and no active or acute Category C events (indicative of AIDS disease) according to guidelines established by the Centers for Disease Control and Prevention.
Summary of Clinical Trials with 908
More than 1,200 people have participated in three Phase III trials to test the safety and efficacy of 908: NEAT, SOLO and CONTEXT. The SOLO study was an open-label trial with 649 HIV+, treatment-nave patients. Participants were randomized to receive either 1400 mg of 908 plus 200 mg ritonavir (908/r) QD or 1250 mg of nelfinavir BID. All also received the two NRTIs, ABC and 3TC. The trial, conducted at more than 100 research centers worldwide, was designed to assess the safety and efficacy of each
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