To: Izzy who wrote (2785 ) 11/14/1997 5:06:00 PM From: JOHN W. Read Replies (1) | Respond to of 6136
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.