title: Protease inhibitor therapy in children with perinatally acquired HIV infection.
abstract: OBJECTIVE
  To review the short-term response and safety of protease inhibitor therapy in HIV-infected children.
  
  
  METHODS
  Retrospective chart review of open-label protease inhibitor-containing combination therapy.
  
  
  METHODS
  Two urban pediatric HIV centers.
  
  
  METHODS
  Twenty-eight HIV-infected children were prescribed 30 protease inhibitor-containing antiretroviral therapy combinations. The median age at initiation of protease inhibitor antiretroviral therapy was 79 months. Patients had been on previous antiretroviral therapy for a mean of 45.5 months.
  
  
  RESULTS
  Of the 28 children who completed at least 1 month of therapy, 26 experienced marked virologic and immunologic improvement (mean maximal decrease in viral load 1.90 log10 copies/ml; SD, 0.8; mean maximal rise in CD4+ lymphocytes of 279 x 10(6)/l; SD, 300 x 10(6)/l). Eleven patients achieved a viral nadir of < 400 copies/ml, and seven sustained this level of viral suppression for a mean of 6 months. Indinavir use was associated with a high incidence of renal side-effects, including two patients who developed interstitial nephritis. Two patients on ritonavir experienced a significant elevation of liver enzymes.
  
  
  CONCLUSIONS
  Protease inhibitor therapy was associated with substantial short-term virologic and immunologic improvement in this primarily heavily pretreated cohort, with 25% maintaining a viral load of < 400 copies/ml after 6 months of therapy. There was a significant rate of adverse events. Pharmacokinetic and safety data are needed to guide aggressive antiretroviral therapy in HIV-infected children, and further treatment options are required for those failing or intolerant to the available protease inhibitors.
authors.affiliation: Division of General Pediatrics, Children's Hospital of Philadelphia, Pennsylvania 19104, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Rutstein
authors.forename: A
authors.initials: A
authors.lastname: Feingold
authors.forename: D
authors.initials: D
authors.lastname: Meislich
authors.forename: B
authors.initials: B
authors.lastname: Word
authors.forename: B
authors.initials: B
authors.lastname: Rudy
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission; D015497:HIV-1; D006801:Humans; D019469:Indinavir / Q000627:therapeutic use; D007223:Infant; D018445:Infectious Disease Transmission, Vertical; D019259:Lamivudine / Q000627:therapeutic use; D008297:Male; D011480:Protease Inhibitors / Q000627:therapeutic use*; D012189:Retrospective Studies; D019438:Ritonavir / Q000627:therapeutic use; D019258:Saquinavir / Q000627:therapeutic use; D018119:Stavudine / Q000627:therapeutic use; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D011480:Protease Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019469:Indinavir; D018119:Stavudine; D019258:Saquinavir; D019438:Ritonavir