A phase II trial of dual protease inhibitor therapy: amprenavir in combination with indinavir, nelfinavir, or saquinavir

J Acquir Immune Defic Syndr. 2001 Apr 15;26(5):458-61. doi: 10.1097/00126334-200104150-00008.

Abstract

This study evaluated dual protease inhibitor (PI) regimens containing amprenavir (APV) in PI-naive, HIV-1-infected patients over 48 weeks. Patients were randomized to 800-mg APV combined with 800-mg indinavir (IDV), 750-mg nelfinavir (NFV), or 800-mg saquinavir-soft gel capsule (SGV-SGC), all three times daily without nucleoside reverse transcriptase inhibitors, or APV given alone for 3 weeks and then with 150-mg lamivudine (3TC) and 300-mg zidovudine (ZDV), twice daily. Dual PI therapy demonstrated substantial antiviral activity and was generally safe and well tolerated. Eight patients had virologic failure; 5 were receiving dual PI therapy and 3 were in the APV/3TC/ZDV arm. The protease I50V mutation characteristic of APV resistance was not observed, although other key PI mutations were selected in 4 patients failing therapy, 2 of whom had PI resistance at baseline.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-HIV Agents / therapeutic use*
  • Carbamates
  • Drug Therapy, Combination
  • Female
  • Furans
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV Protease Inhibitors / therapeutic use*
  • HIV-1 / physiology*
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • RNA, Viral / blood
  • Reverse Transcriptase Inhibitors / therapeutic use
  • Sulfonamides / therapeutic use*
  • Treatment Outcome

Substances

  • Anti-HIV Agents
  • Carbamates
  • Furans
  • HIV Protease Inhibitors
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Sulfonamides
  • amprenavir