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

MAR-21-1997 11:43 FROM MHHD PUBLIC AFFAIRS TO 916199424979 P.004/006

All patients in the initial phase of the trial are eligible to continue in the new extension phase.
Patients will receive CRIXIVAN in an "unblinded" or "open-label" format, meaning that volunteers and
their doctors will have full knowledge about what medications are being used. Other licensed antiretroviral medications, such as AZT and 3TC, also may be added to CRIXIVAN in this phase at the
discretion of the patient's doctor. Patients will continue to be monitored by physicians at one of 5 Brazil
study sites, and followed within the study to assess the extended benefit of treatment with CRIXIVAN.
The results of the study indicate a significant clinical benefit in both CRIXIVAN-containing arms.
The reduction in risk for disease progression and death over that seen for the AZT group was 70
percent for the group taking the combination of CRIXIVAN and AZT, compared to 61 percent for the
CRIXIVAN monotherapy arm versus the AZT arm.
CRIXIVAN Effective in All HIVDisease Stages
Phase III and Phase IV trials of CRIXIVAN are ongoing, and results reported to date indicate
that CRIXIVAN can be used effectively in patients at all stages of HIV disease:
* HIV/AIDS (CD4 count 400 cells/mm?)
- Progression to opportunistic infections, cancers and death reduced by approximately
50 percent with CRIXIVAN in triple combination with AZT and 3TC. [ACTG-320
(patients = 1,156)/Feb.1997
* Progression to AIDS-defining conditions (opportunistic infections, cancer or death)
reduced by almost two-thirds with CRIXIVAN alone or in combination with AZT.
[Brazil Protocol 028 (patients = 996)/March 1997)
a Viral load reduced below assay level of quantification (500 copies/mU) in 86 percent
of patients treated with CRIXIVAN in triple combination, up to 68 weeks. [Protocol
035 (patients = 97)/Jan. 1997)
* Advanced AIDS (CD count 60 cellsnw3)
Viral load reduced below assay level of quantification (500 copieslmL) in 65 percent
of patients treated with CRIXIVAN in triple combination with AZT and 3TC, up to 24
weeks. (Protocol 039 (patients = 320)/Jan. 19973
* Early HIV Disease (within 3 months of Infection)
Viral load reduced below assay level of quantification (500 copies/mL) in all patients
treated with CRIXIVAN in triple combination with AZT and 3TC, up to 4 to 9 months.
(Protocol 042 (patients = 36)/Jan. 1997]
Currently, 135,000 patients around the world are taking CRIXIVAN, which is now approved in 48
countries and has been studied in more than 3,000 patients world-wide.