Crixivan« (Indinavir): Three Doses Daily, Not Two, in Most Regimens
On September 18 Merck & Co., Inc. announced that it had discontinued clinical trials with twice-daily dosing of indinavir (Crixivan) in combination with nucleoside analogs only. However, it is still continuing studies of twice-daily indinavir dosing in combination with protease inhibitors nelfinavir or ritonavir (which increase the time that indinavir stays in the bloodstream). The FDA-approved dosing of indinavir is every eight hours, but many patients had switched to twice daily after an earlier small trial had suggested that the two regimens might be equivalent.The twice-daily dosing was discontinued after a new larger trial found that at 24 weeks, 91% of those on the approved three-times dosing regimen had a viral load below 400 copies, compared to only 64% of those with twice-daily dosing. A total of 87 patients had reached the 24-week time point and were included in this comparison. Besides the indinavir, participants in both treatment arms were taking AZT plus 3TC. They had not been treated with protease inhibitors, or with 3TC, before beginning this study.
Discontinuation rates were low and similar in both groups.
Also, there was a trend toward more discontinuation of the twice-daily regimen due to nausea and vomiting.
Persons using indinavir twice daily should promptly check with their physicians about options for modifying their treatment.
