Sex-based differences in saquinavir pharmacology and virologic response in AIDS Clinical Trials group study 359

Courtney V. Fletcher, Hongyu Jiang, Richard C. Brundage, Edward P. Acosta, Richard Haubrich, David Katzenstein, Roy M. Gulick

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84 Scopus citations


AIDS Clinical Trials Group study 359 was a controlled study of saquinavir with either ritonavir or nelfinavir, together with delavirdine, adefovir, or both, in indinavir-experienced persons. Saquinavir was common in all study arms, and the study investigated relationships among characteristics of patients, saquinavir area under the curve (AUC) and trough concentrations (C min), and virologic response. Concentrations of saquinavir were higher when it was combined with ritonavir than when it was combined with nelfinavir and were lower with adefovir-containing regimens. Females had higher AUC and Cmin values than did males. Higher saquinavir AUC and C min values were associated with a greater likelihood of human immunodeficiency virus (HIV) RNA levels ≤500 copies/mL (P = .008) and were better predictors of response than was the saquinavir inhibitory quotient Males had a lower probability of having HIV RNA levels ≤500 copies/mL at week 16 than did females (28% vs. 42%; adjusted odds ratio, 0.43). In this study, a greater proportion of females had HIV RNA levels ≤500 copies/mL than did males, which can be attributed to higher concentrations of saquinavir in females than in males.

Original languageEnglish (US)
Pages (from-to)1176-1184
Number of pages9
JournalJournal of Infectious Diseases
Issue number7
StatePublished - Apr 1 2004

Bibliographical note

Funding Information:
Received 15 August 2003; accepted 17 October 2003; electronically published 16 March 2004. Presented in part: 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment, Paris, France, 15 July 2003 (abstract 128). Financial support: National Institutes of Health (grants AI38858, AI38855, AI46386, AI51966, AI27666, AI32775, RR00047, and RR00070). Potential conflicts of interest: R.M.G. has received research grants from Abbott Laboratories, is an ad hoc consultant for Abbott Laboratories and ViroLogic, and has received speaker’s honoraria from Roche Pharmaceuticals. Reprints or correspondence: Dr. Courtney V. Fletcher, Dept. of Clinical Pharmacy, University of Colorado Health Sciences Center, 4200 East Ninth Ave., Campus Box C-238, Denver, CO 80262, (


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