Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS Clinical Trials Group protocol 373

J Infect Dis. 2001 Mar 1;183(5):715-21. doi: 10.1086/318820. Epub 2001 Jan 30.

Abstract

This prospective, multicenter, open-label study was designed to determine the antiretroviral activity and safety of a 4-drug regimen: 1000 mg indinavir every 8 h with 200 mg nevirapine, 40 mg stavudine, and 150 mg lamivudine, each given twice daily in amprenavir-experienced subjects. The primary end points of the study were the human immunodeficiency virus (HIV) RNA level and CD4 cell count responses. Fifty-six subjects were enrolled and were changed from amprenavir-containing regimens to the 4-drug regimen. Overall, at week 48, 33 (59%) of 56 subjects had HIV RNA levels <500 copies/mL (intent-to-treat analysis, where missing values equal > or =500 copies/mL) and CD4 cell counts increased by 94 cells/mm(3) from baseline. Subjects who had previously taken amprenavir combination therapy were more likely to experience virologic failure than those who had taken amprenavir monotherapy (odds ratio, 7.7; P=.0012). In this study, most subjects who had taken amprenavir-based regimens and who changed to a 4-drug regimen achieved subsequent durable virologic suppression.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Carbamates
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Female
  • Furans
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • Humans
  • Indinavir / administration & dosage
  • Indinavir / therapeutic use
  • Lamivudine / administration & dosage
  • Lamivudine / therapeutic use
  • Male
  • Nevirapine / administration & dosage
  • Nevirapine / therapeutic use
  • Odds Ratio
  • Prospective Studies
  • RNA, Viral / analysis*
  • Safety
  • Stavudine / administration & dosage
  • Stavudine / therapeutic use
  • Sulfonamides / administration & dosage
  • Sulfonamides / therapeutic use
  • Time Factors
  • Treatment Outcome
  • Viral Load

Substances

  • Anti-HIV Agents
  • Carbamates
  • Furans
  • RNA, Viral
  • Sulfonamides
  • Lamivudine
  • amprenavir
  • Indinavir
  • Nevirapine
  • Stavudine