Protease inhibitor therapy in children with perinatally acquired HIV infection

AIDS. 1997 Oct;11(12):F107-11. doi: 10.1097/00002030-199712000-00004.


Objective: To review the short-term response and safety of protease inhibitor therapy in HIV-infected children.

Design: Retrospective chart review of open-label protease inhibitor-containing combination therapy.

Setting: Two urban pediatric HIV centers.

Patients: 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.

Publication types

  • Case Reports

MeSH terms

  • Anti-HIV Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / transmission
  • HIV-1*
  • Humans
  • Indinavir / therapeutic use
  • Infant
  • Infectious Disease Transmission, Vertical
  • Lamivudine / therapeutic use
  • Male
  • Protease Inhibitors / therapeutic use*
  • Retrospective Studies
  • Ritonavir / therapeutic use
  • Saquinavir / therapeutic use
  • Stavudine / therapeutic use
  • Zidovudine / therapeutic use


  • Anti-HIV Agents
  • Protease Inhibitors
  • Lamivudine
  • Zidovudine
  • Indinavir
  • Stavudine
  • Saquinavir
  • Ritonavir