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Update on Glaxo Wellcome's 141W94
141W94 Abstract (ICAAC)
Dr. Chip Schooley of the University of Colorado Health Sciences Center presented preliminary data on the safety and effectiveness of 141W94 in HIV+ individuals with CD4 counts between 150 and 400 cells/mm3.
The phase I/II study was designed to determine the safety, tolerance, and acute antiviral activity of open-label, multiple oral doses of 141W94 alone. Participants with no prior antiretroviral therapy were treated with 141W94 for a period of 4 weeks.
Participants were assigned to one of four treatment arms: 300 mg twice daily of 141W94 (cohort 1); 300 mg three times daily of 141W94 (cohort 2); 900 mg twice daily of 141W94 (cohort 3); and 1,200 mg twice daily of 141W94 (cohort 4).
At baseline, median viral load levels were 4.72 logs in cohort 1 (9 persons), 4.84 logs in cohort 2 (12 persons), 4.75 logs in cohort 3 (9 persons), and 5.04 logs in cohort 4 (7 persons). Median CD4 counts at baseline were 254 cells/mm3 in cohort 1 (10 persons), 303 cells/mm3 in cohort 2 (9 persons), 305 cells/mm3 in cohort 3, and 265.5 cells/mm3 in cohort 4.
Over the 4 week primary treatment period, reductions in median maximum viral load levels from baseline were 0.58 log in cohort 1, 1.025 logs in cohort 2, 1.69 logs in cohort 3, and 1.95 logs in cohort 4. Median maximum increases in CD4 counts above baseline over the same period were 64 cells/mm3 in cohort 1, 85 cells/mm3 in cohort 2, 35 cells/mm3 in cohort 3, and 110 cells/mm3 in cohort 4.
Clinical adverse event data were available for 39 of the 42 participants. Mild (grade 1 or 2) diarrhea/loose stools, rash, and headache occurred in more than 10% of participants. Three participants discontinued and withdrew from the study, two due to a grade 3 rash and one due to worsening of pre-existing colitis.
Based on very preliminary evidence, 141W94 penetrated the central nervous system (CNS) in a small number of study participants. Additional analyses of human CNS tests are in progress.
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