title: Comparison of two antiretroviral triple combinations including the protease inhibitor indinavir in children infected with human immunodeficiency virus.
abstract: OBJECTIVE
  The effects of two antiretroviral triple combinations including the protease inhibitor indinavir on the surrogate markers, viral load and CD4 cells were evaluated.
  
  
  METHODS
  Fifteen patients with high viral load or disease progression under their prior antiretroviral therapy were switched to zidovudine/lamivudine/indinavir (Group A, n = 10) or stavudine/lamivudine/indinavir (Group B, n = 5). Serial determinations of viral load and CD4 cells were performed.
  
  
  RESULTS
  The median reduction of the viral load was 0.6 log after 3 months and 0.8 log after 6 months in Group A and 2.5 and 2.4 log after 3 and 6 months in Group B, respectively. After 3 and 6 months 3 of 10 patients in Group A and 3 of 5 patients in Group B had viral load reductions below the detection limit of the assay. Patients with an additional switch of nucleoside analogues at start of indinavir therapy (regardless of the specific reverse transcriptase inhibitor used) had significantly better reductions of the viral load than patients without such a switch (median 2.3 log vs. 0.2 log after 6 months, P < 0.05). In Group A the median of the relative increase of CD4 cells was 37% after 3 months and 57% after 6 months (P = 0.002); in Group B the medians of the relative increase of CD4 cells were 145 and 163% (not significant), respectively. Two patients from Group A and 1 from Group B developed renal calculi, which resolved after adequate hydration. One patient was withdrawn because of intractable vomiting attributed to indinavir.
  
  
  CONCLUSIONS
  In a small cohort of HIV-infected pediatric patients with extensive prior antiretroviral treatment, triple therapy including indinavir had a sustained effect on the decrease of the viral load and the increase of CD4 cells similar to results obtained in antiretrovirally experienced adults. This effect was significantly better in patients with an additional switch of a nucleoside analogue at start of triple therapy with indinavir than in patients without such a change.
authors.affiliation: Children's Hospital, Ludwig Maximilians-University Munich, Germany. ida@KKi.med.uni-muenchen.de
authors.forename: U
authors.initials: U
authors.lastname: Wintergerst
authors.forename: F
authors.initials: F
authors.lastname: Hoffmann
authors.forename: B
authors.initials: B
authors.lastname: Sölder
authors.forename: G
authors.initials: G
authors.lastname: Notheis
authors.forename: T
authors.initials: T
authors.lastname: Petropoulou
authors.forename: J
authors.initials: J
authors.lastname: Eberle
authors.forename: L
authors.initials: L
authors.lastname: Gürtler
authors.forename: B H
authors.initials: BH
authors.lastname: Belohradsky
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D006801:Humans; D019469:Indinavir / Q000627:therapeutic use*; D007223:Infant; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019469:Indinavir