A critical evaluation of the therapeutic range of indinavir.
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.


METHODS
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.


METHODS
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.


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


CONCLUSIONS
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.
Rayner
Craig R
CR
Department of Pharmacy Practice, Victorian College of Pharmacy, Monash University, Parkville, Australia. craig.rayner@vcp.monash.edu.au
Galbraith
Kirsten J
KJ
Marriott
Jennifer L
JL
Duncan
Gregory J
GJ
D000328:Adult; D019540:Area Under Curve; D002648:Child; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring / Q000379:methods*; D005069:Evaluation Studies as Topic; D006678:HIV / Q000187:drug effects / Q000235:genetics; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D006801:Humans; D019469:Indinavir / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
D017320:HIV Protease Inhibitors; D019469:Indinavir