title: Clinical utility of HIV-1 genotyping and expert advice: the Havana trial.
abstract: OBJECTIVE
  To determine whether HIV-1 genotyping and expert advice add additional short-term virologic benefit in guiding antiretroviral changes in HIV+ drug-experienced patients.
  
  
  METHODS
  A two factorial (genotyping and expert advice), randomized, open label, multi-center trial. The patients were stratified according to the number of treatment failures.
  
  
  METHODS
  HIV-1 infected patients on stable antiretroviral therapy who presented virological failure were included into the study. Genotypic testing was performed by using TrueGene HIV Genotyping kit and the results were interpreted by a software package (RetroGram, version 1.0). An expert advisory committee suggested the new therapeutic approach based on clinical information alone or on clinical information plus HIV-1 genotyping results. Plasma HIV-1 RNA load, CD4+ cell count and adverse events were recorded at baseline and every 12 weeks.
  
  
  RESULTS
  A total of 326 patients were included. The baseline CD4+ cell count and plasma HIV-1 RNA were 387 (+/- 224) x 10(6) cells/l and 4 (+/- 1) log(10) respectively. The proportion of patients with plasma HIV-1 RNA < 400 copies/ml at 24 weeks differed between genotyping and no genotyping arms (48.5 and 36.2%, P < 0.05). Factors associated with a higher probability of plasma HIV-1 RNA < 400 copies/ml were HIV-1 genotyping [odds ratio (OR), 1.7; 95% confidence interval (CI), 1.1-2.8; P = 0.016] and the expert advice in patients failing to a second-line antiretroviral therapy (OR, 3.2; 95% CI, 1.2-8.3; P = 0.016).
  
  
  CONCLUSIONS
  HIV-1 genotyping interpreted by a software package improves the virological outcome when it is added to the clinical information as a basis for decisions on changing antiretroviral therapy. The expert advice also showed virologic benefit in the second failure group.
authors.affiliation: HIV Clinical Unit and IrsiCaixa Retrovirology Laboratory, Hospital Universitari Germans Trias i Pujol, Universitat Autónoma de Barcelona, Badalona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Tural
authors.forename: Lidia
authors.initials: L
authors.lastname: Ruiz
authors.forename: Christopher
authors.initials: C
authors.lastname: Holtzer
authors.forename: Jonathan
authors.initials: J
authors.lastname: Schapiro
authors.forename: Pompeyo
authors.initials: P
authors.lastname: Viciana
authors.forename: Juan
authors.initials: J
authors.lastname: González
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Charles
authors.initials: C
authors.lastname: Boucher
authors.forename: C
authors.initials: C
authors.lastname: Rey-Joly
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D008297:Male; D008511:Medicine; D015999:Multivariate Analysis; D013030:Spain; D013038:Specialization; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents