Subject: BI wants to dance
Date: Fri, Nov 14, 1997 16:03 EST
From: Taurus8266
Message-id: <19971114210301.QAA16159@ladder02.news.aol.com>
Study Under Way to Investigate
Three-Drug Alternative
Authors: Richard S. Ferri, PhD, ANP, ACRN, Richard L. Witt, PA-C, Victoria L. Sharp, MD
[Clinician Reviews 7(10):103-104, 1997. c 1997 Clinicians Publishing Group and Williams & Wilkins.]
A new open-label clinical trial exploring drug interactions and antiviral activity
with therapy combining nevirapine, nelfinavir, and stavudine opened recently.
It is being conducted at two major medical centers--Roger Williams Hospital
in Providence, RI, and HIVCare at Saint Francis Memorial Hospital in San
Francisco, Calif.
Eligible patients are HIV-1-infected adults who have not yet taken protease
inhibitors or nonnucleoside RTIs, and have taken stavudine for less than 6
months or not at all. Other criteria include CD4+ T-cell counts >100
cells/mm3, and HIV-1 RNA concentrations >5,000 copies/mL. Patients who
meet these qualifications and have failed to respond to zidovudine and
lamivudine will also be eligible for enrollment.
The potential pharmacokinetic interaction between nevirapine and nelfinavir in
HIV-1-infected adults treated with stavudine will be investigated in the first
part of the trial. In the second, the long-term antiviral effect of the three-drug
combination on viral load as measured by HIV-1 RNA will be evaluated. In
addition, CD4+/CD8+ T-cell counts and percentages will be employed to
measure immunologic parameters. The efficacy of the trial treatment will be
evaluated during a 1-year follow-up period.
The trial medications and continuing viral load and CD4+ T-cell count testing
are provided without charge. This is not a placebo-controlled trial, and all
participants will receive all three drugs. Participants will be enrolled in the
study for as long as the drug therapy suppresses HIV-1 below the level of
detection.
This clinical trial is a collaborative effort by Boehringer Ingelheim
Pharmaceuticals, Inc, makers of nevirapine; Agouron Pharmaceuticals, Inc,
makers of nelfinavir; and Bristol-Myers Squibb Immunology, makers of
stavudine. Healthcare professionals and HIV-1-infected adults who are
interested in this clinical trial should call Gail Skowron, MD, at (401)
456-2437, or Sher Vieira at (415) 353-6215.
Boehringer Ingelheim Pharmaceuticals, Inc.
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