A critical evaluation of the therapeutic range of indinavir

Abstract

Objective: To provide a summary of the patient population, study characteristics, and important findings of the key studies in the literature evaluating concentration-effect relationships and the therapeutic range for indinavir.

Data sources: Literature search strategy involved using MEDLINE (1966-July 2001) and AIDSLINE (MEDSCAPE) databases (up to July 2001). Reference lists from primary literature and review articles were also examined, and conference abstracts were obtained.

Study selection: English-language articles were considered suitable for review if the clinical trials in HIV patients reported on concentration-effect relationships and/or pharmacokinetic breakpoints or threshold concentrations. A search of the literature identified 20 peer-reviewed references from 18 separate studies including journal articles and conference abstracts.

Data extraction: The targeted pharmacokinetic parameters and breakpoint values, the rationale for their selection or method of identification, and other study details and limitations were summarized.

Discussion: This article highlights the heterogeneity of studies evaluating the therapeutic range of indinavir and provides a summary of important findings of the key studies in the literature evaluating concentration-effect relationships and therapeutic range. Tables are provided to enable clinicians to make use of currently available information on the therapeutic range of indinavir.

Conclusions: There is insufficient evidence to recommend a general therapeutic range for indinavir. Future investigations should incorporate both pharmacokinetics and pharmacodynamics in order to define a broadly applicable therapeutic range.