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

Twice-Daily Results Promising
Eight studies covering nearly 1,000 patients have been completed or are
planned to examine CRIXIVAN taken twice-daily in combination therapies,
including Merck Protocols 054, 067, 061, 069 and 076. Other studies are ACTG
368, a study by Nelson et al in the UK, a Spanish BID study by Gatell et al and
the BID Safety and Efficacy Trial (BEST), a study being conducted by a group of
international AIDS treatment specialists which is getting underway this month.
The largest and longest-running study, Merck Protocol 054, looked at
CRIXIVAN in combination with lamivudine (3TC) and zidovudine (AZT). It
recruited 87 patients who had not been previously treated with protease
inhibitors or lamivudine, and randomised them to CRIXIVAN three-times-a-day
(800mg q8h), or CRIXIVAN twice-daily at two different dose levels (1000mg/
1200mg q12h). All patients received twice-daily lamivudine (150mg q12h) and
zidovudine (AZT, 300mg q12h).
Results at 32 weeks showed that both the twice-daily CRIXIVAN dose
arms had roughly equal efficacy, with the 1000mg arm 76 percent of patients
with undetectable viral load (viral RNA <500 copies/ml), while the 1200mg arm
showed 75 percent. The three-times-a-day arm showed slightly lower levels of
efficacy, with 54 percent of patients with virus levels below detectable limits.
Discontinuations due to drug intolerance were similar in all three arms of the
study.
Merck Protocol 067 recruited 71 patients and randomised them to either
CRIXIVAN three-times-a-day (1000mg q8h) combined with the non-nucleoside
reverse transcriptase inhibitor efavirenz once-daily (600mg qd) or CRIXIVAN
twice-daily (1200mg q12h) with efavirenz twice-daily (300mg q12h). Interim
results from patients who have received 16 weeks of therapy show that six out of
seven patients in the CRIXIVAN three-times-a-day arm had undetectable levels
of viral load (<400 copies/mI), compared to six out of eight patients in the twicedaily arm. Study drugs were generally well tolerated: of the 71 patients enrolled,