Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Wednesday October 14, 1998
"This study is a critical step forward in better understanding the treatment of HIV/AIDS in women," said Carmen Zorrilla, MD, professor of obstetrics and gynecology at the University of Puerto Rico School of Medicine and principal investigator of the trial. "Recent statistics show that women comprise 45 percent of new HIV infections, but they account for only 9 to 15 percent of research study participants."
The trial is designed to determine whether gender differences exist in response to anti-HIV treatment, including viral suppression and CD4 cell count. The study will also compare viral load levels in vaginal secretions to that in the blood, to determine whether decreased viral load in the blood is reflected in a similar decrease of viral load in the tissues, or conversely, whether the vaginal area remains an HIV reservoir, hiding the virus from treatment.
The trial will also attempt to answer the important question of whether there are drug interactions between FORTOVASE and oral contraceptives that might affect the efficacy of either drug. In order for physicians to determine effective birth control methods for their HIV-positive patients, the relationship between FORTOVASE and oral contraceptives must be understood.
"Historically, the treatment of HIV/AIDS has not focused on women. This is a fast-growing population for the epidemic, yet women are understudied," said Dr. Sandra Palleja, medical director at Roche Laboratories. "At Roche we have put women's research at the forefront of our clinical program to address women's treatment needs."
The open-label study is expected to enroll 60 women and 20 men in 20 centers nationwide. For more information on this trial, please call 1-800-TRIALS-A. About Hoffmann-La Roche Inc.
Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that discovers, develops, manufactures and markets numerous important prescription drugs that improve, prolong and save the lives of patients with serious illnesses. Among the company's areas of therapeutic interest are virology, including HIV and AIDS, infectious diseases, cardiology, neurology, oncology, transplantation, dermatology and obesity.
The company provides a wide range of medications in the United States through its marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in Nutley, N.J., both companies are members of the Basel, Switzerland-based Roche Group, a global leader in health care with principal businesses in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors.
For further information about FORTOVASE(TM) Patients can call: 800-910-4687 Healthcare Professionals: 800-526-6367
Roche HIV Therapy Assistance Program: 800-282-7780 FORTOVASE Website: http://www.fortovase.com
For a copy of the FORTOVASE product package insert with complete prescribing information please call: Amy Sunshine at 973-562-2373.
FORTOVASE(TM) is a trademark of Hoffmann-La Roche Inc.
SOURCE: Hoffmann-La Roche
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