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Design of Viral Dynamic Studies for Efficiently Assessing Potency of Anti‐HIV Therapies in AIDS Clinical Trials
Author(s) -
Wu Hulin,
Ding A. Adam
Publication year - 2002
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/1521-4036(200203)44:2<175::aid-bimj175>3.0.co;2-3
Subject(s) - clinical trial , human immunodeficiency virus (hiv) , viral load , medicine , clinical study design , sensitivity (control systems) , monte carlo method , computer science , intensive care medicine , immunology , mathematics , statistics , pathology , engineering , electronic engineering
The study of HIV dynamics is one of the most important developments in recent AIDS research. It greatly improves our understanding of the pathogenesis of HIV infection. Recently it has been proposed to use HIV dynamics to evaluate the efficacy of antiviral treatments. Currently a large number of AIDS clinical trials on HIV dynamics are in development worldwide. However, many design issues that arise from HIV dynamic studies have not been addressed. In this paper, we study these problems using intensive Monte Carlo simulations and analytic methods. We evaluate a finite number of feasible candidate designs, which are currently used and proposed in AIDS clinical trials from different perspectives. We compare the viral dynamic marker and classical viral load change markers in terms of power for identifying treatment difference, asymptotic relative efficiency, and sensitivity. Finally we propose some useful suggestions for practitioners based on our results.