Open-label study of a twice-daily indinavir 800-mg/ritonavir 100-mg regimen in protease inhibitor-naive HIV-infected adults

J Acquir Immune Defic Syndr. 2002 Dec 15;31(5):478-82. doi: 10.1097/00126334-200212150-00004.

Abstract

Low-dose ritonavir can boost plasma levels of indinavir, thereby enhancing its antiretroviral activity despite less frequent dosing. In this open-label, noncomparative, 24-week trial with a 24-week extension phase, HIV-infected protease inhibitor (PI)- and lamivudine-naive adults received indinavir/ritonavir 800 mg/100 mg plus stavudine and lamivudine every 12 hours. The proportions of patients achieving plasma HIV RNA (vRNA) <400 and <50 copies/mL were analyzed with data as observed (DAO) and intention-to-treat models using generalized estimating equations (GEE) or counting noncompleters as failures (NC = F). Eighty-nine patients (80% men) with a median age of 36 years and mean baseline vRNA levels and CD4 counts of 5.01 log(10) copies/mL and 269 cells/mm(3) were enrolled. The proportions (95% confidence interval [CI]) of patients achieving vRNA <400 copies/mL were 93% (84%, 98%), 78% (67%, 86%), and 68% (57%, 78%) at week 24 for DAO, GEE, and NC = F analyses, respectively; the corresponding results at week 48 were 95% (84%, 99%), 65% (53%, 76%), and 45% (35%, 57%). Most patients with vRNA <400 had <50 copies/mL. At week 48, baseline vRNA decreased by >2 log(10) copies/mL and CD4 counts increased by approximately 200 cells/mm(3). Five patients (6%) experienced serious drug-related adverse experiences. Twenty patients (23%) discontinued therapy due to adverse experiences. In this study, twice-daily indinavir 800 mg/ritonavir 100 mg with two nucleoside reverse transcriptase inhibitors provided potent viral suppression and immunologic reconstitution in many PI-naive patients.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Anemia / chemically induced
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use
  • CD4 Lymphocyte Count
  • Dehydration / chemically induced
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • HIV / drug effects
  • HIV / genetics
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • HIV Protease Inhibitors / administration & dosage*
  • HIV Protease Inhibitors / adverse effects
  • HIV Protease Inhibitors / therapeutic use*
  • Humans
  • Indinavir / administration & dosage*
  • Indinavir / adverse effects
  • Indinavir / therapeutic use*
  • Kidney Diseases / chemically induced
  • Lipoproteins / blood
  • Lipoproteins / drug effects
  • Logistic Models
  • Male
  • Middle Aged
  • Pneumonia / chemically induced
  • RNA, Viral / analysis
  • Ritonavir / administration & dosage*
  • Ritonavir / adverse effects
  • Ritonavir / therapeutic use*
  • Virus Replication

Substances

  • Anti-HIV Agents
  • HIV Protease Inhibitors
  • Lipoproteins
  • RNA, Viral
  • Indinavir
  • Ritonavir