HIV AIDS News [International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

only two patients in the twice-daily group and one in the three-times daily group
required discontinuation of CRIXIVAN or efavirenz due to adverse events.
These results are consistent with those of the Spanish BID study by
Gatell et al presented in September 1997 at the Infectious Diseases Society of
America (IDSA) meeting, in which twice-daily CRIXIVAN was found to be as
efficacious and well tolerated as the current three-times-a-day regimen.
With 620 patients planned, ongoing Merck Protocol 069 is an example of
the Company's commitment to more convenient dosing regimens for CRIXIVAN.
Protocol 069 will be the largest study to examine twice-daily dosing with
CRIXIVAN in combination with AZT and 3TC.
Meanwhile, Merck Protocol 061 is examining CRIXIVAN twice-daily in
combination with nelfinavir. Data for 24 weeks covering 21 patients indicate that
this may be another avenue for future exploration.
"These preliminary results are encouraging in determining the effect of a
twice-daily dosing regimen with CRIXIVAN," according to Bach-Yen Nguyen,
M.D., associate director of Clinical Research at Merck Research Laboratories,
who presented the data at the ICAAC meeting. "In addition, the BID Efficacy and
Safety Trial (BEST) will recruit 300 patients to provide additional data that the
easier-to-use regimen will suppress HIV below detection as well as the current
dosing regimen for CRIXIVAN."
Worldwide Availability
Currently, more than 160,000 patients around the world are taking
CRIXIVAN, the world's most widely prescribed protease inhibitor. CRIXIVAN is
now approved in more than 80 countries, and has been studied in more than
4,000 patients worldwide.