Med Monitor

In a Phase II clinical trial, Merck experimental integrase inhibitor raltegravir (Isentress) demonstrated positive results for both treatment-experienced and treatment-naive patients, according to researchers. In the study of patients with resistance to protease inhibitors, nucleoside reverse transcriptase inhibitors, or nonnukes, at week 24 of receiving raltegravir 71% achieved viral loads below 400, compared to 16% receiving a placebo. ----- ----- ----- In another Phase II trial, reported in July at the International AIDS Society conference, patients achieved undetectable viral loads (less than 50) with all four doses of raltegravir studied (100, 200, 400, or 600 milligrams twice daily) in treatment-naive patients infected with HIV. In addition, raltegravir showed minimal impact on total and LDL ('bad') serum cholesterol, serum triglycerides, and the ratio of total cholesterol to HDL cholesterol. ----- ----- ----- In a Phase III study comparing a once-daily treatment regimen of Truvada and Sustiva to a twice-daily regimen of Combivir with once-daily Sustiva, reported by Gilead Sciences, after 144 weeks of treatment the Truvada-Sustiva regimen was associated with significantly greater virologic suppression compared to the Combivir-based regimen and also caused greater increases in CD4 cell counts and fewer side effects. ----- ----- ----- Testosterone MD-Lotion effectively and safely restored testosterone levels into the normal range with no adverse side effects, according to results of an eight-month Phase II trial reported by Australian biotech company Acrus. The lotion is dosed via a roll-on applicator to the armpits of men with low testosterone levels. ----- ----- ----- Tibotec Pharmaceuticals filed in late July with the Food and Drug Administration an application for approval to sell etravirine (also known as TMC-125), a new candidate in the nonnuke class of antiretrovirals. ----- ----- ----- Boehringer Ingelheim has started enrolling patients for a Phase IIIb trial of protease inhibitor Aptivus, which will look at the efficacy of the drug across a range of race and gender. The project will examine safety, efficacy, and pharmacokinetics in a racially diverse group of 200 female and 200 male treatment-experienced patients across eight countries at 72 sites on three continents.