The information on this site is intended for healthcare professionals in the United States and is not intended for the general public.
The information on this site is intended for healthcare professionals in the United States and is not intended for the general public.
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The initial trials were just to make sure that the drug was generally well tolerated. Once that had been determined by the trial in healthy volunteers in June 1993, a 12-day study to test the safety of CRIXIVAN and the effect of CRIXIVAN on HIV was begun. Of the 10 patients in the test, 8 were given CRIXIVAN and 2 received AZT. The 12-day study showed that CRIXIVAN was generally well tolerated and had good antiviral activity. The results were so positive that Merck decided to gear up a larger 60-patient safety and efficacy (Phase III) trial of CRIXIVAN at 200 mg and 400 mg every 6 hours. A 600-mg dose every 4 hours was added later during the study.
By July 1993, CRIXIVAN showed a significant antiviral effect when measured by decreases in p24 antigen (a standard measure at the time for the level of HIV in the bloodstream) and plasma viral RNA. Also, patients taking CRIXIVAN showed increases in CD4 counts — a measure of the strength of the immune system — and even gained weight. Merck continued the clinical program with CRIXIVAN.
