AIDS Progression Reduced by Almost Two-Thirds with Protease Inhibitor Crixivan, Brazil Trial Shows

MARR21-1997 11:43 FROM MHHD PUBLIC AFFAIRS TO 916199424979 P.006/006
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FACT SHEET
Contact: Stephen Hull
+ 908 423 3086
CRIXIVAN CLINICAL STUDY SUMMARY:
PROTOCOL 028 w CLINICAL ENDPOINT TRIAL
Objective To evaluate the safety and efficacy for the combination of CRIXIVAN* (Indinavir) + ALT
(zidovudine), compared to CRIXIVAN alone (monotherapy) versus AZT monotherapy, in
HIV-1 seropositive antiretroviral-nalve patients with CD4 counts between 50 and 250
cells/mm3.
Design Randomized, double blind, phase III clinical trial. During the study, the protocol was
amended to add 3TC to the AZT-containing arms.
Primary Endpoint Progression to an AIDS-defining condition (opportunistic infection, cancer or death)
Secondary Endpoint Changes in viral RNA and CD4 ceil counts
Patients 996 seropositive, AZT-naive patients; CD4 cell counts between 50 and 250 cells/mm3
Median baseline CD4 = 147 cellslmm. Median baseline viral RNA 4 30,051 copiesimI
(4.48 log9c copies/mI).
Demographics 28% female, 72% male; 88% white, 11% Black/Mulatto, 1% other (predominately Asian)
Sites 5 treatment centers in Brazil (Sao Paulo and Campinas)
Timellne First patient enrolledw April 1995; Preliminary analysis - March 1997.
Preliminary Results
* CRIXIVAN reduced the risk of an AIDS-defining condition (opportunistic infection, cancer or death) by almost
two-thirds compared to AZT nionotherapy.
* Over a median follow-up of 58 weeks (range 12-102 weeks), 107 patients of the 996 enrolled had protocol
defined clinical events. 6% (20) patients on CRIXIVAN + AZT had an AIDS-defining condition compared with
7.8% (26) patients on CRIXIVAN alone and 18% (61) patients on AZT monotherapy.
* Both CRIXIVAN-containing arms demonstrated a significant reduction in disease progression compared to
ALT. CRIXIVAN + ALT achieved 70% risk reduction. CRIXIVAN monotherapy achieved 61% risk reduction.
(The difference between the CRIXIVAN-containlng arms was not statistically significant.)
* The average decrease in viral load over follow up was -1.03 log10 for ORIXIVAN + ALT; -0.76 log10 for
CRIXIVAN monotherapy; and -0.25 lo% ) for ALT monotherapy.
* The average increase in 004 cells/mm' over follow up was 112 cells for CRIXI VAN + ALT; 103 cells for
CRIXI VAN monotherapy; and 21 cells for ALT monotherepy.
* The percentage of patients who achieved viral RNA levels below assay level of quantIfication (500 copieslmL.),
at median follow up of 58 weeks, were: 42% of patients on CRIXI VAN + ALT; 34% of patients on CRIXIVAN
monbtherapy; and 9% of patients on AZT monotherapy.
CRlXI VAN (indinavir) is a registered trademark of Merck & Co., Inc., Whitehouse Station, New Jersey, USA.

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