Randomized controlled trial of once-daily tenofovir, lamivudine, and lopinavir/ritonavir versus remaining on the same regimen in virologically suppressed HIV-infected patients on their first PI-containing HAART regimen

HIV Clin Trials. 2007 Sep-Oct;8(5):259-68. doi: 10.1310/hct0805-259.

Abstract

Purpose: To assess the effects of switching to once-daily (QD) lopinavir/ritonavir (LPV/r)-based combination therapy in HIV-infected patients who are virologically suppressed (HIV viral load <50 copies/mL) on their first protease inhibitor (PI)-containing regimen.

Method: In this 48-week, prospective, open-label, randomized study, patients were either switched to once-daily LPV/r, tenofovir (TDF), and lamivudine (3TC) (QD arm) or remained on their existing regimen (control arm). The primary endpoint of the study was the proportion of patients maintaining virologic suppression following 48 weeks of treatment.

Results: Fifty and 22 patients were randomized to the QD and control arms, respectively. At week 48, there was no significant difference in virological suppression between the QD and control arms using intent-to-treat (missing = failure) analysis (p = .44). There was no significant difference in discontinuation rates between the two arms (p = .66). Significantly more patients randomized to the QD arm reported gastrointestinal adverse events compared with the control arm (p = .009). There were no study drug-related serious adverse events.

Conclusion: For patients who are already virologically suppressed on their first PI-containing regimen, switching to a QD regimen of TDF+3TC+LPV/r resulted in similar rates of virologic suppression when compared with staying on existing therapy.

Publication types

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

MeSH terms

  • Adenine / administration & dosage
  • Adenine / adverse effects
  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use
  • Adult
  • Antiretroviral Therapy, Highly Active
  • Female
  • HIV Infections / drug therapy*
  • HIV Protease Inhibitors / administration & dosage*
  • HIV Protease Inhibitors / adverse effects
  • HIV Protease Inhibitors / therapeutic use
  • Humans
  • Lamivudine / administration & dosage*
  • Lamivudine / adverse effects
  • Lamivudine / therapeutic use*
  • Lopinavir
  • Male
  • Middle Aged
  • Organophosphonates / administration & dosage*
  • Organophosphonates / adverse effects
  • Organophosphonates / therapeutic use*
  • Prospective Studies
  • Pyrimidinones / administration & dosage*
  • Pyrimidinones / adverse effects
  • Pyrimidinones / therapeutic use
  • Ritonavir / administration & dosage*
  • Ritonavir / adverse effects
  • Ritonavir / therapeutic use
  • Tenofovir
  • Viral Load

Substances

  • HIV Protease Inhibitors
  • Organophosphonates
  • Pyrimidinones
  • Lopinavir
  • Lamivudine
  • Tenofovir
  • Adenine
  • Ritonavir