Four measures of antiretroviral medication adherence and virologic response in AIDS clinical trials group study 359

Courtney V. Fletcher, Marcia A. Testa, Richard Brundage, Margaret A. Chesney, Richard Haubrich, Edward P. Acosta, Ana Martinez, Hongyu Jiang, Roy M. Gulick

Research output: Contribution to journalArticlepeer-review

42 Scopus citations


AIDS Clinical Trials Group (ACTG) 359 was a randomized, partially double-blinded factorial study of 6 antiretroviral regimens, all including saquinavir, among HIV-infected persons in whom prior therapy had failed (n = 258). Counts of remaining saquinavir capsules were determined between weeks 0 and 4; at weeks 4, 8, and 16, self-reported adherence was estimated from 2-day report of doses skipped, therapeutic coverage, and percent of doses taken were determined by electronic monitoring devices applied to saquinavir bottles, and the saquinavir 24-hour area under the curve (AUC) was estimated. Relationships were evaluated among these 4 adherence measures and the primary endpoint of week 16 HIV RNA change. Thirty percent of 254 subjects had HIV RNA <500 copies/mL at week 16. Only self-reported adherence and saquinavir AUC were significantly associated with week 16 HIV RNA change (P = 0.019 and 0.023, respectively), and these measures were higher in subjects with week 16 HIV RNA <500 copies/mL (P = 0.03 and 0.008, respectively). The ability to detect a correlation between electronically monitored adherence and virologic response was limited by the small sample size. Self-reported adherence and saquinavir AUC were significant predictors of virologic response, in this evaluation. These findings provide insight into methods of assessing and improving adherence to antiretroviral regimens.

Original languageEnglish (US)
Pages (from-to)301-306
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes
Issue number3
StatePublished - Nov 1 2005


  • Adherence
  • Antiretroviral therapy
  • Pill counts
  • Self-reported adherence
  • Virologic response

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