Important note: Information in this article was accurate in May 2004. The state of the art may have changed since the publication date.
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AIDSWEEKLY Plus; Monday, May 24, 2004
Staff Medical Writers
"Tipranavir (TPV), a novel nonpeptidic protease inhibitor (NPPI), was administered to treatment-naive HIV-1-infected patients over 14 days in a randomized, multicenter, open-label, parallel-group trial to evaluate the efficacy and tolerability of a self-emulsifying drug delivery system (SEDDS) formulation, in combination with ritonavir (RTV)," wrote researchers in the Journal of Acquired Immunodeficiency Syndromes.
"Of the 31 patients enrolled, 10 were randomized to receive TPV 1200 mg twice daily (TPV 1200), 10 patients received TPV 300 mg + RTV 200 mg twice daily (TPV/r 300/200), and 11 patients received TPV 1200 mg + RTV 200 mg twice daily (TPV/r 1200/200). The median baseline viral load and CD4 cell count were 4.96 log10 copies/mL and 244 cells/mm3, respectively," McCallister and colleagues reported.
"After 14 days, the median decrease in viral load was -0.77 log10 in the TPV 1200 group, -1.43 log10 in the TPV/r 300/200 group, and -1.64 log10 in the TPV/r 1200/200 group. TPV exposure was increased by 24- and 70-fold in the TPV/r 300/200 and 1200/200 groups, respectively, compared with TPV 1200 alone," said McCallister.
"There were no significant differences across treatment arms with regard to drug-related adverse events. TPV/r appeared to be safe, effective, and well tolerated during 14 days of treatment," investigators concluded.
Mccallister and colleagues published the results of their research in Journal of Acquired Immune Deficiency Syndromes (A 14-day dose-response study of the efficacy, safety, and pharmacokinetics of the nonpeptidic protease inhibitor tipranavir in treatment-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2004 Apr 20;35(4):376-382.
For additional information, contact S. Mccallister, Boehringer Ingelheim Pharmaceutical Inc., 900 Ridgebury Rd., Ridgefield, CT 06877, USA.
The publisher of the Jaids - Journal of Acquired Immune Deficiency Syndromes can be contacted at: Lippincott Williams & Wilkins, 530 Walnut St., Philadelphia, PA 19106-3621, USA.
The information in this article comes under the major subject areas of AIDS and HIV, Pharmaceutical & Drug Development and Antiretroviral.
This article was prepared by AIDS Weekly editors from staff and other reports.
Reference
McCallister S, Valdez H, Curry K, et al., "A 14-Day Dose-Response Study of the Efficacy, Safety, and Pharmacokinetics of the Nonpeptidic Protease Inhibitor Tipranavir in Treatment-Naive HIV-1-Infected Patients", J Acquir Immune Defic Syndr. 2004 Apr 20;35(4):376-382
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