title: A Multicenter, Open Labeled, Randomized, Phase III Study Comparing Lopinavir/Ritonavir Plus Atazanavir to Lopinavir/Ritonavir Plus Zidovudine and Lamivudine in Naive HIV-1-Infected Patients: 48-Week Analysis of the LORAN Trial.
abstract: OBJECTIVE
  The primary aim of the study was to compare the metabolic side effects of a nucleoside analogue-containing regimen with a nucleoside analogue-sparing double protease inhibitor regimen. A secondary goal was to test for efficacy of a double-PI regimen.
  
  
  METHODS
  Multicenter, randomized, open-label, phase III clinical trial.
  
  
  METHODS
  Adult HIV-1-infected individuals naïve to antiretroviral therapy with viral load above 400 HIV-RNA copies/ml were randomized (1:1) to either 400 mg lopinavir /100 mg ritonavir (LPV/r) BID plus 150 mg lamivudine/300 mg zidovudine (CBV) BID versus LPV/r BID plus 300 mg atazanavir (ATV) QD. Main outcome measure was the virologic failure in both groups, defined as viral load ≥50 copies/ml at week 48.
  
  
  RESULTS
  In the CBV/LPV/r-arm, 29 out of 35 patients [(83%; 95% confidence interval (CI) 66.9-92.2%] and 18 out of 40 patients (45%; 95% CI 29.7-61.5%) in the ATV/LPV/r-arm had a HIV-RNA level <50 copies/ml at week 48. The intent-to-treat analysis revealed inferior virologic response in the ATV/LPV/r arm (Chi-Q and Fisher´s Exact Test p<0.001) and resulted in premature termination of the trial. Eleven patients in the ATV/LPV/r-arm discontinued therapy because of virological failure. These failures mostly presented with low level replication (<1,000 copies/ml). Increases in CD4 cell counts was significantly more rapid in the ATV/LPV/r arm (p=0.02), but comparable at week 48.
  
  
  CONCLUSIONS
  ATV/LPV/r had less virologic efficacy than the conventional RTI-based regimen and resulted in a high virological failure rate with low level replication.
authors.affiliation: Department for Clinical Immunology and Rheumatology, Hannover Medical School, Hannover, Germany.
authors.forename: K U
authors.initials: KU
authors.lastname: Ulbricht
authors.forename: G M
authors.initials: GM
authors.lastname: Behrens
authors.forename: M
authors.initials: M
authors.lastname: Stoll
authors.forename: B
authors.initials: B
authors.lastname: Salzberger
authors.forename: H
authors.initials: H
authors.lastname: Jessen
authors.forename: A B
authors.initials: AB
authors.lastname: Jessen
authors.forename: B
authors.initials: B
authors.lastname: Kuhlmann
authors.forename: H
authors.initials: H
authors.lastname: Heiken
authors.forename: A
authors.initials: A
authors.lastname: Trein
authors.forename: R E
authors.initials: RE
authors.lastname: Schmidt