Kimberly A Struble1, Kirk M Chan-Tack, Guoxing Greg Soon. 1. Office of New Drugs, Office of Antimicrobial Products, Division of Antiviral Products, US Food and Drug Administration, USA. Kimberly.struble@fda.hhs.gov
Abstract
PURPOSE OF REVIEW: To provide a regulatory perspective on developing new HIV protease inhibitors. The present review highlights the risks and benefits of certain design aspects for studies in treatment-naïve and treatment-experienced patients, including timing of studies, study design options, choice of control arms, and duration of treatment. RECENT FINDINGS: The present review highlights published studies to illustrate the need for new therapies and highlights potential historical data to help design future HIV clinical trials better. SUMMARY: New antiretroviral agents for patients with multidrug resistance, including safer, more convenient therapies without significant drug-drug interactions, are still needed for all patients. The goals of therapy have evolved and the expectation for treatment regimens is that the majority of patients, including treatment-experienced patients, will achieve undetectable HIV RNA. New study designs, particularly for treatment-experienced patients, are needed to help identify potential risks and benefits of new treatments.
PURPOSE OF REVIEW: To provide a regulatory perspective on developing new HIV protease inhibitors. The present review highlights the risks and benefits of certain design aspects for studies in treatment-naïve and treatment-experienced patients, including timing of studies, study design options, choice of control arms, and duration of treatment. RECENT FINDINGS: The present review highlights published studies to illustrate the need for new therapies and highlights potential historical data to help design future HIV clinical trials better. SUMMARY: New antiretroviral agents for patients with multidrug resistance, including safer, more convenient therapies without significant drug-drug interactions, are still needed for all patients. The goals of therapy have evolved and the expectation for treatment regimens is that the majority of patients, including treatment-experienced patients, will achieve undetectable HIV RNA. New study designs, particularly for treatment-experienced patients, are needed to help identify potential risks and benefits of new treatments.
Authors: Arna H Arnardottir; Flora M Haaijer-Ruskamp; Sabine M J Straus; Pieter A de Graeff; Peter G M Mol Journal: Drug Saf Date: 2011-11-01 Impact factor: 5.606