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Substitution of nevirapine because of efavirenz toxicity in AIDS clinical trials group A5095.

Abstract
In AIDS Clinical Trials Group A5095, 9% of participants who experienced an adverse event related to efavirenz substituted nevirapine. Most adverse events resolved; 15 participants ultimately discontinued nevirapine therapy. Grade 3/4 hepatotoxicity was observed in 14% of individuals who substituted nevirapine, compared with 6% who continued efavirenz therapy. Substitution of nevirapine because of efavirenz toxicity was generally safe and efficacious. Clinical trials registration. NCT00013520 .
AuthorsJeffrey T Schouten, Amy Krambrink, Heather J Ribaudo, Anne Kmack, Nancy Webb, Cecilia Shikuma, Daniel R Kuritzkes, Roy M Gulick
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 50 Issue 5 Pg. 787-91 (Mar 01 2010) ISSN: 1537-6591 [Electronic] United States
PMID20121419 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Alkynes
  • Antiviral Agents
  • Benzoxazines
  • Cyclopropanes
  • Nevirapine
  • efavirenz
Topics
  • Acquired Immunodeficiency Syndrome (drug therapy)
  • Adult
  • Alkynes
  • Antiviral Agents (adverse effects, therapeutic use)
  • Benzoxazines (adverse effects, therapeutic use)
  • Cyclopropanes
  • Female
  • Humans
  • Liver (drug effects)
  • Male
  • Middle Aged
  • Nevirapine (adverse effects, therapeutic use)
  • Withholding Treatment

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