Clinical, virologic and immunologic responses of children with advanced human immunodeficiency virus type 1 disease treated with protease inhibitors

Pediatr Infect Dis J. 1997 Oct;16(10):968-74. doi: 10.1097/00006454-199710000-00013.


Objective: To determine the effects of combination antiretroviral therapy including a protease inhibitor (PI combination therapy) in children with advanced HIV-1 disease.

Study design: An observational study of HIV-1 plasma RNA, lymphocyte subsets, delayed type hypersensitivity and physical growth after initiation of PI combination therapy.

Results: In nine children the median HIV-1 plasma RNA decreased 1.7 log10 (mean, 1.57; range, 0.7 to 2.2) following PI combination therapy and CD4 cells increased a median of 499 (mean, 528; range, 9 to 1088) cells/microl. A rebound of RNA, associated with the development of resistance to the PI, occurred in three subjects. Three of six children were no longer anergic and all nine achieved normal weight-growth velocities. Ritonavir was well-tolerated, despite its bitter taste; however, four of five children treated with indinavir developed renal complications.

Conclusions: PI combination therapy in children with advanced HIV-1 disease was associated with a decrease in HIV-1 RNA, improved immunologic measures and normal or better weight gain. Of concern was the rebound in plasma HIV-1 associated with resistance to the PI observed in one-third of patients. This emphasizes the need for larger studies to define optimal PI containing regimens with long term efficacy in children.

Publication types

  • Clinical Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Anti-HIV Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Child
  • Child, Preschool
  • Drug Resistance, Microbial / genetics
  • Drug Therapy, Combination
  • Growth
  • HIV Infections / drug therapy*
  • HIV Infections / physiopathology
  • HIV Protease Inhibitors / therapeutic use*
  • HIV-1* / genetics
  • HIV-1* / isolation & purification
  • Humans
  • Hypersensitivity, Delayed
  • Infant
  • Viral Load


  • Anti-HIV Agents
  • HIV Protease Inhibitors