title: Switch from enfuvirtide to raltegravir in virologically suppressed multidrug-resistant HIV-1-infected patients: a randomized open-label trial.
abstract: BACKGROUND
  Among patients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection, salvage regimens including enfuvirtide have demonstrated sustained efficacy. Because of reluctance to use subcutaneous injections, raltegravir may be an alternative to replace enfuvirtide within a suppressive regimen. We conducted a prospective, randomized, open-label trial to compare the antiviral efficacy and safety of a switch to raltegravir with the efficacy and safety of continuing enfuvirtide.
  
  
  METHODS
  A total of 170 patients with multidrug-resistant HIV-1 infection and plasma HIV-1 RNA levels <400 copies/mL who were receiving enfuvirtide-based regimens were randomized 1:1 to maintain enfuvirtide or to switch to raltegravir. The primary efficacy end point was the cumulative proportion of patients with virologic failure, defined as a confirmed plasma HIV-1 RNA level >or=400 copies/mL, over 24 weeks. The secondary end points mainly involved safety.
  
  
  RESULTS
  The switch to raltegravir was non-inferior to the maintenance of enfuvirtide, with virologic failure rates of 1.2% in both treatment arms in the intention-to-treat analysis (beta = 0.01%; 95% confidence interval, -6.7 to 6.8) and 1.2% and 0%, respectively, in the on-treatment analysis (beta = 1.22%; 95% confidence interval, -5.6 to 8.1). At week 24, 88%-89% of patients in both arms had plasma HIV-1 RNA levels <50 copies/mL. No significant CD4 cell count changes occurred in either arm. Grade 3-4 adverse events and laboratory abnormalities were uncommon and were not different between the treatment arms.
  
  
  CONCLUSIONS
  A switch to raltegravir was safe, well tolerated, and virologically non-inferior to the maintenance of enfuvirtide in patients infected with multidrug-resistant HIV-1 infection who were receiving suppressive antiretroviral therapy.
  
  
  BACKGROUND
  NCT00454337
authors.affiliation: Department of Infectious Diseases, Assistance Publique Hôpitaux de Paris, Saint-Louis Hospital and University of Paris VII Denis Diderot, Paris, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: De Castro
authors.forename: Joséphine
authors.initials: J
authors.lastname: Braun
authors.forename: Isabelle
authors.initials: I
authors.lastname: Charreau
authors.forename: Gilles
authors.initials: G
authors.lastname: Pialoux
authors.forename: Laurent
authors.initials: L
authors.lastname: Cotte
authors.forename: Christine
authors.initials: C
authors.lastname: Katlama
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.forename: Laurence
authors.initials: L
authors.lastname: Weiss
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Meynard
authors.forename: Yazdan
authors.initials: Y
authors.lastname: Yazdanpanah
authors.forename: Constance
authors.initials: C
authors.lastname: Delaugerre
authors.forename: Isabelle
authors.initials: I
authors.lastname: Madelaine-Chambrin
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Molina
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D024921:Drug Resistance, Multiple, Viral; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000009:adverse effects / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D011760:Pyrrolidinones / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D015700:HIV Envelope Protein gp41; D010446:Peptide Fragments; D011760:Pyrrolidinones; D012367:RNA, Viral; D000077560:Enfuvirtide; D000068898:Raltegravir Potassium