title: Efficacy and safety of ritonavir/indinavir 100/400 mg twice daily in combination with two nucleoside analogues in antiretroviral treatment-naive HIV-infected individuals.
abstract: OBJECTIVE
  To evaluate the efficacy and tolerability of indinavir/ritonavir (IDV/RTV) 400/100 mg twice daily in combination with two nucleoside reverse transcriptase inhibitors in antiretroviral-naive patients.
  
  
  METHODS
  Antiviral therapy-naive patients with plasma HIV-1 RNA > 5000 copies/ml were enrolled in this pilot, single-arm study. CD4 cell count and viral load were evaluated at weeks (W) 4, 12, 24 and every 3 months until W48. The primary end-point was the percentage (%) of patients with viral load < 400 copies/ml at W48. Intent-to-treat (ITT) (missing values or change in treatment equalled failure) and on-treatment (OT) analyses were performed.
  
  
  RESULTS
  Forty patients were enrolled. Baseline median viral load was 5.36 log10 copies/ml, median CD4 count was 84 cells/mm3. At W48 by ITT analysis, the % patients with viral load < 400 copies/ml was 65% (95% CI: 48-79) and 50% (95% CI: 35-65) with viral load < 50 copies/ml, and 96% (26/27) (95% CI: 89-100) and 74% (95% CI: 57-91], respectively, by OT analysis. The median decrease in viral load at W48 was -3.83 log10 copies/ml (-0.1; -5.19) and the median increase in CD4 was +167 cells/mm3 (6-474 cell/mm3). At W4 (34/40), the median IDV C(min) was 500 ng/ml (range 5-8100) with 91% of patients with an adequate IDV C(min) > 150 ng/ml. Ten patients discontinued the study treatment before W48: adverse events (eight), patient's will (one) and simplification of therapy (one). Three patients were lost to follow-up. Only one virological failure occurred and was associated with poor compliance and sub-optimal concentrations of IDV/RTV.
  
  
  CONCLUSIONS
  IDV/RTV 400/100 mg twice daily is an effective and safe first-line antiretroviral therapy. The simplicity and the low cost of IDV/RTV is of major interest particularly in countries with limited resources.
authors.affiliation: Department of Infectious Diseases, Pitié Salpétrière Hospital, Paris, France. claudine.duvivier@psl.ap-hop-paris.fr
authors.forename: Claudine
authors.initials: C
authors.lastname: Duvivier
authors.forename: Astriti
authors.initials: A
authors.lastname: Myrto
authors.forename: Anne-Geneviève
authors.initials: AG
authors.lastname: Marcelin
authors.forename: Jade
authors.initials: J
authors.lastname: Ghosn
authors.forename: Hocine
authors.initials: H
authors.lastname: Ait-Mohand
authors.forename: Luminita
authors.initials: L
authors.lastname: Schneider
authors.forename: Rachid
authors.initials: R
authors.lastname: Agher
authors.forename: François
authors.initials: F
authors.lastname: Bricaire
authors.forename: Dominique
authors.initials: D
authors.lastname: Costagliola
authors.forename: Vincent
authors.initials: V
authors.lastname: Calvez
authors.forename: Gilles
authors.initials: G
authors.lastname: Peytavin
authors.forename: Christine
authors.initials: C
authors.lastname: Katlama
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D016049:Didanosine / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D019469:Indinavir / Q000008:administration & dosage; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019438:Ritonavir / Q000008:administration & dosage; D018119:Stavudine / Q000008:administration & dosage; D015215:Zidovudine / Q000008:administration & dosage
chemical_list: D019380:Anti-HIV Agents; D019259:Lamivudine; D015215:Zidovudine; D019469:Indinavir; D018119:Stavudine; D016049:Didanosine; D019438:Ritonavir