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

I-I I\/N11IA,
AIDSMSD
For Immediate Release
Contacts: Janet Skidmore Kelley Dougherty
[phone] [phone]
During the World AIDS Conference:
Hotel Des Bergues [phone]
Efavirenz- CLINICAL TRIAL UPDATE
DMP 266-003 CRIXIVANTM* (indinavir) in a novel double-combination with
Cohort IV efavirenz in nRTI-experienced patients
* 101 patients randomised to efavirenz (200mg qd increased to
600mg qd at 36 weeks) plus CRIXIVAN (800/1000mg q8h), or
CRIXIVAN alone. Monotherapy arm discontinued at week 12;
patients offered option of adding efavirenz and stavudine
(D4T) to align with current treatment standards. Mean HIV
RNA = 5.06 log10, mean CD4 283 cells/mm3.
* 60-week data showed that 89 percent of patients on
CRIXIVAN/efavirenz combination had undetectable viral load
(<400 copies/mL). The data were presented at the 5th
Conference on Retroviruses and Opportunistic Infections,
February 1998.
* 72-week data to be presented at the 12th World AIDS
Conference, Geneva, June 1998
PROTOCOL 067 CRIXIVAN in combination with efavirenz in PI- and NNRTInaive patients, in a novel twice-daily regimen
* 71 patients randomised to either three-times-a-day therapy
with CRIXIVAN 1000mg q8h plus efavirenz (600mg qd) or a
new twice-daily regimen with CRIXIVAN (1200mg q12h) plus
efavirenz (300mg q12h)
* Interim analysis at 16 weeks suggests that the safety profile
and antiviral activity of twice-daily dosing are comparable to
the current standard of CRIXIVAN three-times-a-day

*CRIXIVANTM is a trademark of Merck & Co., Inc., Whitehouse Station, New Jersey, USA