Long-term responses to treatment including ritonavir or nelfinavir in HIV-1-infected children. Pediatric AIDS Group of Switzerland

Infection. 2000 Sep;28(5):287-96. doi: 10.1007/s150100070021.


Background: Knowledge concerning the long-term antiretroviral and immunological efficacy of protease inhibitors in children is limited.

Patients and methods: An open-label, prospective, multicenter clinical trial was conducted over a period of 72 weeks in Switzerland. 60 HIV-1 infected children (aged 0.3-16.9 years) naive to protease inhibitors were enrolled. Ritonavir or nelfinavir and at least one new nucleoside reverse transcriptase inhibitor were introduced into the current treatment regimen. HIV-1 RNA levels and CD4 cell counts were monitored after introducing the protease inhibitor, and the tolerability and safety of the drugs were assessed.

Results: Dictated by chronological availability, 37 children received ritonavir and 23 nelfinavir. At baseline, children given ritonavir had higher mean plasma HIV-1 RNA levels (5.03 vs 4.63 log10 copies/ml; p = 0.001) and lower mean CD4 cell counts (277 vs 555 cells/microl; p = 0.009) than children given nelfinavir. Antiretroviral treatment (ART) naive children showed higher mean plasma HIV-1 RNA levels than non-naive (5.18 vs 4.64 log10 copies/ml; p = 0.02). The decline in plasma HIV-1 RNA levels 72 weeks after treatment with ritonavir and nelfinavir was -2.17 and -1.30 log10 copies/ml, respectively (p = 0.006) and in ART-naive vs non-naive patients -2.70 vs -1.39 log10 copies/ml (p < or = 0.01). 69% of ART-naive patients and 32% of non-naive patients achieved sustained plasma HIV-1 RNA levels < 400 copies/ml. Increases in CD4 cells were higher in ART-naive compared to non-naive patients (p < 0.04).

Conclusion: The antiretroviral and immunologic benefits of protease inhibitors are more profound in ART-naive than in non-naive children.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • CD4 Lymphocyte Count
  • Child
  • Child, Preschool
  • Drug Therapy, Combination
  • Female
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV Protease Inhibitors / therapeutic use*
  • HIV-1* / genetics
  • HIV-1* / isolation & purification
  • Humans
  • Infant
  • Male
  • Nelfinavir / adverse effects
  • Nelfinavir / therapeutic use*
  • Prospective Studies
  • RNA, Messenger / blood
  • RNA, Viral / blood
  • Reverse Transcriptase Inhibitors / therapeutic use*
  • Ritonavir / adverse effects
  • Ritonavir / therapeutic use*


  • HIV Protease Inhibitors
  • RNA, Messenger
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Nelfinavir
  • Ritonavir