The Amplicor HIV-1 Monitor(TM); Key Indicator of Efficacy in Recent Clinical Trials

06/03/96 15:26 RMIS BmANC HBUFI3, 500/3 908-2537809 - 916199424979NO45 6

NO.457 D06

Clinical Trials BackgwouudedlPage 2
Merck Trials: CRXI VN (indifavir):
CRIXIVNO therapy (2.4 g/d), and some
Studies have shown that CRDCIVAN~ )m~
signficantly (<500 copies/nit in about 4O0
studies have shown that combination te
approximately 1.3 log reduction in HIV R'
sustained at the 24-week evaluation. Add
therapy (CRIXIVAN0/AZTf3TC) suggest
AMPLICOR HW-1 MONVITORTMT Test can1
24 weeks. The triple combination reduced
copies/niL).
All Merck Phase II lV RNA data were
MONITORM Test at Consolidated Laboral
Abbott Trials: NORWIRTM (ritornwir): M
the Abbott clinical Trials of NORVIR~r (6C0
therapy results in significant reductions in
log to 2.9 logs in various studies). FlIV RD,
reductions in viral load occurred with coixVIT)
The data from phase I/I stuadies show that
log reductions in viral load by eight weeks
viral load had again risen, but a sustained
demonstrated. In the Phase III trial involv

tore than 2,000 individuals have received
have been treated for longer than 26 months.
notherapy reduces HIV RNA levels
percent of treated patients. Similarly, larger
spy with AZT/CRIXIVAN results in an
A at four and 12 weeks, an effect that was
tion~ally, small studies with triple combination
that undetectable levels of HIV RNA by the
tc achieved in up to 90 percent of individuals at
median virus levels by >99 percent (>2.0 log
nerated with the AMPLICOR 1fV-1
ryies.
r than 2,000 people with AIDS participated in
fmg SWD). The results show that NORVIRThI
FIIV RNA levels (with peak reductions of 1.4
Atesting also showed that the most dramatic
binatlon therapy (involving AZT, ddC and
doaeof 60Omg Itresuted in apeaksof tea
iniiatonof therapy. By 32 weeks, the
riediari viral load reduction of one log was
qi 1,090 patients with <100 CI)4 cells, a fourdin #t 42 percent reduction in mortality and a
kint of mortality or progression to AIDS.
was 1.4 log, which occuerredattwo week~rster 1