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

Clin Infect Dis. 2010 Mar 1;50(5):787-91. doi: 10.1086/650539.

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 .

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acquired Immunodeficiency Syndrome / drug therapy*
  • Adult
  • Antiviral Agents / adverse effects*
  • Antiviral Agents / therapeutic use*
  • Benzoxazines / adverse effects*
  • Benzoxazines / therapeutic use*
  • Female
  • Humans
  • Liver / drug effects
  • Male
  • Middle Aged
  • Nevirapine / adverse effects*
  • Nevirapine / therapeutic use*
  • Withholding Treatment

Substances

  • Antiviral Agents
  • Benzoxazines
  • Nevirapine
  • efavirenz

Associated data

  • ClinicalTrials.gov/NCT00013520