title: Efficacy and safety of switching from boosted lopinavir to boosted atazanavir in patients with virological suppression receiving a LPV/r-containing HAART: the ATAZIP study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of switching from boosted lopinavir (LPV/r) to boosted atazanavir (ATV/r) in virologically suppressed HIV-1-infected patients versus continuing LPV/r.
  
  
  METHODS
  Forty-eight weeks analysis of a randomized, open-label, noninferiority trial including patients with virological suppression (< or = 200 copies/mL for > or = 6 months) on LPV/r-containing triple highly active antiretroviral therapy. Patients (n = 248) were randomized 1:1 either to continue LPV/r twice a day (n = 127) or to switch to ATV/r every day (ATV/r; n = 121), with no change in nucleoside reverse transcriptase inhibitor backbone. Those known to have >4 protease inhibitor (PI)-associated mutations and/or who had failed >2 PI-containing regimens were excluded.
  
  
  RESULTS
  Baseline characteristics were balanced. 30% harboured > or = 1 PI-associated mutation (10% harboured > or = 1 major mutation). Treatment failure at 48 weeks (primary end point) occurred in 20% (25 of 127) of the LPV/r arm and in 17% (21 of 121) of the ATV/r arm (difference -2.3%; 95% confidence interval: -12.0 to 8.0; P = 0.0018). Virological failure occurred in 7% (9 of 127) of the LPV/r arm and in 5% (6 of 121) of the ATV/r arm (difference -2.1%; 95% confidence interval: -8.7% to 4.2%, P < 0.0001 for noninferiorating). CD4 changes from baseline were similar in each arm (approximately 40 cells/mm). Adverse event rate leading to study drug discontinuation was 5% in both arms. Median fasting triglycerides and total cholesterol decreased significantly in the ATV/r arm (-53 and -19 mg/dL, respectively versus -4 and -4 mg/dL in the LPV/r arm; P < 0.001 in both comparisons). Alanine aminotransferase/aspartate aminotransferase hepatic abnormalities were similar in the 2 arms.
  
  
  CONCLUSIONS
  Switching to ATV/r in virologically suppressed patients who were receiving a LPV/r-containing highly active antiretroviral therapy provided comparable (noninferior) efficacy and a safety profile with improved lipid parameters [ISRCTN24813210].
authors.affiliation: Hospital Clinic Universitari-IDIBAPS, University of Barcelona, Barcelona, Spain. mallolas@clinic.ub.es
authors.forename: Josep
authors.initials: J
authors.lastname: Mallolas
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
authors.forename: Ana
authors.initials: A
authors.lastname: Milinkovic
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: Esteve
authors.initials: E
authors.lastname: Ribera
authors.forename: Félix
authors.initials: F
authors.lastname: Gutiérrez
authors.forename: Hernando
authors.initials: H
authors.lastname: Knobel
authors.forename: Jaime
authors.initials: J
authors.lastname: Cosin
authors.forename: Elena
authors.initials: E
authors.lastname: Ferrer
authors.forename: José Alberto
authors.initials: JA
authors.lastname: Arranz
authors.forename: Victor
authors.initials: V
authors.lastname: Roca
authors.forename: Francesc
authors.initials: F
authors.lastname: Vidal
authors.forename: Javier
authors.initials: J
authors.lastname: Murillas
authors.forename: Judit
authors.initials: J
authors.lastname: Pich
authors.forename: Enric
authors.initials: E
authors.lastname: Pedrol
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
authors.forename: David
authors.initials: D
authors.lastname: Dalmau
authors.forename: Isabel
authors.initials: I
authors.lastname: García
authors.forename: Miquel
authors.initials: M
authors.lastname: Aranda
authors.forename: Ana
authors.initials: A
authors.lastname: Cruceta
authors.forename: Esteban
authors.initials: E
authors.lastname: Martínez
authors.forename: José L
authors.initials: JL
authors.lastname: Blanco
authors.forename: Elisa de
authors.initials: Ed
authors.lastname: Lazzari
authors.forename: José M
authors.initials: JM
authors.lastname: Gatell
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D023241:Antiretroviral Therapy, Highly Active; D001219:Aspartate Aminotransferases / Q000097:blood; D000069446:Atazanavir Sulfate; D024882:Drug Resistance, Viral / Q000235:genetics; D004361:Drug Tolerance; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006801:Humans; D008055:Lipids / Q000097:blood; D008099:Liver / Q000187:drug effects; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009842:Oligopeptides / Q000008:administration & dosage* / Q000009:adverse effects; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D011744:Pyrimidinones / Q000008:administration & dosage* / Q000009:adverse effects; D012449:Safety
chemical_list: D019380:Anti-HIV Agents; D008055:Lipids; D009842:Oligopeptides; D011725:Pyridines; D011744:Pyrimidinones; D061466:Lopinavir; D000069446:Atazanavir Sulfate; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase