Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
PRNewswire - November 4, 2002
Five universities are participating in the study, titled "Measurement of HIV Protease Inhibitors in Patient Sera." The clinical sites are: Northwestern University (Chicago, IL), University of Illinois - Chicago (Chicago, IL), University of California San Francisco (San Francisco, CA), University of Miami (Miami, FL) and Wayne State University, (Detroit, MI).
The estimated four-month study is being conducted on a population represented by male and female patients, ages 18-50, treated with protease inhibitors as part of their Highly Active Antiretroviral Therapy (HAART) for HIV infection. The objective of the study is to determine if Levoprin-ZG, when used as a therapeutic drug monitoring tool, will be an objective predictor of medication adherence with each of the five available protease inhibitors: Amprenavir(TM), Lopinavir(TM), Saquinavir(TM), Nelfinavir(TM) and Indinavir(TM).
Monitoring adherence to protease inhibitors is critically important. When HIV-AIDS patients adhere to prescribed regimens, protease inhibitor drugs represent one of the best defenses to combat and control the growth and spread of the HIV virus. However, patient nonadherence has proven to contribute to the development of drug resistant strains of HIV, generally resulting in a poor clinical outcome.
"Adherence is key to successful treatment, and Levoprin-ZG(TM), an objective, point-of-care detection method, may offer a significant medical benefit by helping clinicians monitor patient drug levels to take appropriate and rapid courses of action," said Richard Novak, MD, Director of the University of Illinois - Chicago HIV-AIDS Project and Norzyme Advisory Board member.
The study intends to satisfy the FDA requirement for approval by comparing clinical parameters, the patient statement of adherence and the laboratory measurement of patient drug levels, with two separate laboratory measurements of protease inhibitor levels: HPLC-MS and Levoprin-ZG. The study also proposes that total protease inhibition capacity (PINC) is the clinically relevant value, and accurately can be assessed with the direct use of Levoprin-ZG.
Norzyme also believes findings concerning the benefits of therapeutic drug monitoring will be advanced as a result of this study, opening the door to additional work in areas such as intracellular drug levels and specific dose adjustment, based on measurements made utilizing Levoprin-ZG.
Upon receiving FDA approval, the Levoprin-ZG test, designed for use at point-of-care, will enable clinicians to administer the test during a routine patient visit and receive same-day results, unlike other methods of assessing the presence and levels of various protease inhibitor drugs, including Liquid Chromatography (LC or HPLC), Ultraviolet Detection (UV) and Mass Spectroscopy (MS). These current methods, which also are cost prohibitive for many patients, often take weeks for physicians to receive results, diminishing the value of the information to clinicians who are unable to take immediate action, such as counseling or intervention.
About Norzyme, Inc.
Norzyme, Inc. is the developer, manufacturer and marketer of in-vitro diagnostic drug monitoring technology for routine clinical use. The company, the result of a technology transfer from the University of Manitoba, has achieved international recognition, with total federal funding awards of more than $1.6 million from the National Institutes of Health, and the presentation of two posters at the July, 2002, XIV International AIDS Conference in Barcelona, Spain. Since its incorporation in February, 2000, Norzyme has been headquartered in Northbrook, IL.
CONTACT: Lisa Kudish of Norzyme, Inc., +1-847-412-1000, lkudish@norzyme.com .
SOURCE Norzyme, Inc.
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