1. Comparison of two indinavir/ritonavir regimens in the treatment of HIV-infected individuals
- Author
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Hulin Wu, Ann Walawander, Joseph J. Eron, Daniel R. Kuritzkes, Scott M. Hammer, John G. Gerber, Elaine Ferguson, Denise Neath, Edward P. Acosta, Alfred J. Saah, Carla Pettinelli, Carl J. Fichtenbaum, and Song Yu
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Population ,Salvage therapy ,HIV Infections ,Indinavir ,Pharmacology ,CD8-Positive T-Lymphocytes ,Gastroenterology ,Drug Administration Schedule ,Pharmacokinetics ,Internal medicine ,medicine ,Ethnicity ,Humans ,Pharmacology (medical) ,education ,Substance Abuse, Intravenous ,education.field_of_study ,Ritonavir ,business.industry ,Area under the curve ,HIV Protease Inhibitors ,Middle Aged ,Viral Load ,CD4 Lymphocyte Count ,Regimen ,Infectious Diseases ,Tolerability ,HIV-1 ,RNA, Viral ,Drug Therapy, Combination ,Female ,business ,medicine.drug - Abstract
Background: Pharmacokinetic enhancement of protease inhibitors (PIs) with low-dose ritonavir (RTV) for salvage therapy is increasingly common. The purpose of this study was to compare the pharmacokinetics, safety, and tolerability of indinavir (IDV)/RTV at 800/200 mg (arm A) and 400/400 mg (arm B) administered twice daily in HIV-infected subjects failing their first PI-based regimen. Methods: A phase I/II, randomized, open-label, 24-week study was conducted. Formal 12-hour pharmacokinetic evaluations were performed, and study visits occurred at baseline; at weeks 1, 2, and 4; and every 4 week thereafter for 24 weeks. Clinical symptoms and laboratory assessments were collected. Subjects were allowed to switch arms because of toxicity. Results: Forty-four subjects were enrolled (22 per arm). IDV pre-dose concentration, maximum plasma concentration and area under the curve were significantly higher in arm A. Fifty-five percent and 45% of subjects in arms A and B responded (
- Published
- 2004