1. Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial
- Author
-
Thierry May, Renaud Verdon, Constance Delaugerre, Isabelle Madelaine-Chambrin, B. Balkau, Jean-Michel Molina, Vincent Calvez, M. Bourlière, Isabelle Charreau, Daniel Sereni, S. Gallien, Jean-Pierre Aboulker, Joséphine Braun, Jacques Reynes, Pierre de Truchis, François Jeanblanc, and M. Korzek
- Subjects
Microbiology (medical) ,Adult ,Male ,medicine.medical_specialty ,Enfuvirtide ,Genotype ,Endpoint Determination ,HIV Infections ,Pilot Projects ,Microbial Sensitivity Tests ,Drug Resistance, Multiple, Viral ,HIV Fusion Inhibitors ,Internal medicine ,Raltegravir Potassium ,medicine ,Humans ,Pharmacology (medical) ,HIV Integrase Inhibitors ,Prospective Studies ,Prospective cohort study ,Darunavir ,Pharmacology ,business.industry ,Alanine Transaminase ,Middle Aged ,Raltegravir ,HIV Envelope Protein gp41 ,Peptide Fragments ,Pyrrolidinones ,Discontinuation ,CD4 Lymphocyte Count ,Regimen ,Infectious Diseases ,Treatment Outcome ,HIV-1 ,RNA, Viral ,Ritonavir ,Female ,France ,business ,Tipranavir ,medicine.drug - Abstract
OBJECTIVES: To assess the sustainable efficacy and safety of a switch from enfuvirtide to raltegravir in patients with multidrug-resistant HIV infection. METHODS: One hundred and seventy patients with multidrug-resistant HIV infection and suppressed plasma HIV RNA levels < 400 copies/mL under an enfuvirtide-based regimen were randomized to maintain their regimen or to switch to a raltegravir-based regimen (immediate group) in a 48 week prospective, randomized, open-label trial. At week 24, patients in the maintenance arm also switched to raltegravir (deferred group). Baseline genotypic susceptibility scores (GSSs) were calculated using available historical resistance tests. Efficacy was assessed by the cumulative proportion of patients with virological failure, defined as a confirmed plasma HIV RNA ≥ 400 copies/mL up to week 48. The EASIER ANRS 138 trial is registered at ClinicalTrials.gov (NCT00454337). RESULTS: At baseline, 86% of patients had plasma HIV RNA levels
- Published
- 2011