LA JOLLA, Calif., Jan. 6 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq-NNM: AGPH) today announced that its HIV protease inhibitor VIRACEPT(R)
(nelfinavir mesylate) will be studied in a large comparative clinical trial
conducted by the Terry Beirn Community Programs for Clinical Research on AIDS
(CPCRA). The clinical endpoint trial will evaluate and compare disease
progression or death in HIV-infected people taking either VIRACEPT +
nucleoside analogues (i.e., AZT, 3TC, ddI, ddC, d4T), or Norvir(R) (ritonavir)
+ nucleoside analogues. Rates of occurrence of adverse events or
discontinuation from the study as well as changes in CD4+ T cells and plasma
HIV RNA will also be compared between the two treatment groups. 1,300 people
with CD4+ T cells of less than or equal to 100 cells/mm3 will be randomized to
either treatment arm and studied for a minimum of one year. Enrollment has
begun at CPCRA sites throughout the United States. The Canadian HIV Trials
Network (CTN) will be collaborating on the study as well. Further enrollment
and site information may be obtained by calling 1-800-TRIALS-A.
Agouron announced last month its submission to the U.S. Food and Drug
Administration (FDA) of a New Drug Application (NDA) covering both tablet and
pediatric powder formulations of VIRACEPT. Equivalent regulatory submissions
are expected to be made in Canada and Europe later this year.
The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA)
is funded by the National Institute of Allergy and Infectious Diseases (NIAID)
of the National Institutes of Health (NIH). The CPCRA was created to extend
the opportunity for participation in AIDS research activities to community-
based clinicians and their patients through the establishment of treatment
research programs in communities where HIV-infected patients live and receive
their primary medical care. A major goal of the CPCRA is to access HIV-
infected populations frequently underrepresented in clinical trials. Hence,
studies conducted by the CPCRA are directed toward all persons with HIV
infection, but specifically target people of color, women, and injecting drug
users.
VIRACEPT is a synthetic chemical compound designed to inhibit HIV protease
-- an enzyme that plays an essential role in the replication of HIV. VIRACEPT
is being developed by Agouron in collaboration with the pharmaceutical
division of Japan Tobacco Inc.
Agouron Pharmaceuticals, Inc. is a pioneer and leader in technologies
permitting the rational design of novel, small molecule drugs based upon the
molecular structures of proteins which play key roles in human disease.
Agouron is currently applying these technologies to the design and development
of novel drugs for treatment of cancer, AIDS, and other serious diseases.
SOURCE Agouron Pharmaceuticals
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CONTACT: Investor: Donna Nichols, Senior Director, Corporate Communications, 619-622-3009, or http://www.agouron.com; or Media: Joy Schmitt, Manager, Product Public Relations, 619-622-3220
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