HAART simplification with lopinavir/ritonavir monotherapy in HIV/HCV co-infected patients starting anti-HCV treatment: a randomised pilot study (KaMon study)

New Microbiol. 2012 Oct;35(4):469-74. Epub 2012 Oct 1.

Abstract

The aim of this randomised, prospective, open-label, multicentre pilot clinical trial was to compare the 48-week toxicity profile of lopinavir/ritonavir (LPV/r) monotherapy with LPV/r-based HAART (KaMon = Kaletra monotherapy) in HIV/HCV patients undergoing HCV treatment. The study involved 30 HIV/HCV co-infected patients naive to anti- HCV therapy. One patient in each arm (6.7%) discontinued anti-HCV therapy because of adverse events. There were no significant between-group differences in terms of the proportion of patients experiencing AEs (p=0.999) or the number of grade 3-4 AEs (p=0.146). No HIV failure was observed. The safety profile of LPV/r monotherapy was similar to that of LPV/r-based HAART, thus encouraging HAART simplification in patients receiving anti-HCV treatment.

Trial registration: ClinicalTrials.gov NCT00437684.

Publication types

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

MeSH terms

  • Adult
  • Anti-HIV Agents / therapeutic use*
  • Antiretroviral Therapy, Highly Active
  • Coinfection / drug therapy*
  • Coinfection / virology
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV-1 / drug effects
  • HIV-1 / physiology
  • Hepacivirus / drug effects
  • Hepacivirus / physiology
  • Hepatitis C / drug therapy*
  • Hepatitis C / virology
  • Humans
  • Lopinavir / therapeutic use*
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Ritonavir / therapeutic use*
  • Young Adult

Substances

  • Anti-HIV Agents
  • Lopinavir
  • Ritonavir

Associated data

  • ClinicalTrials.gov/NCT00437684