Optimal clinical trial designs for immune-based therapies in persistent viral infections

doi:10.1186/1476-9433-1-4

Medical Immunology

Volume 1

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Commentary

Optimal clinical trial designs for immune-based therapies in persistent viral infections

Kendall A Smith

Weill Medical College of Cornell University Division of Immunology, Department of Medicine 1300 York Avenue, Box 41 New York, NY 10021, USA

Medical Immunology 2002, 1:4doi:10.1186/1476-9433-1-4


Published:	21 November 2002

Abstract

There is now effective therapy for infection by the Human Immunodeficiency Virus (HIV), but there is no cure. Consequently, antiviral drugs must be administered continuously to suppress viral replication. Recently, a large phase III international immune-based therapy trial was discontinued because it is difficult to measure clinical endpoints while antivirals are administered. Since the immune system has evolved under the selective force of microbial infections, the immune reaction is antiviral. This commentary explores the rationale of using "Diagnostic Treatment Interruptions" of antiviral therapies to determine efficacies of immune-based therapies.