Efavirenz liquid formulation in human immunodeficiency virus-infected children

Stuart E. Starr, Courtney V. Fletcher, Stephen A. Spector, Richard C. Brundage, Florence H. Yong, Steven D. Douglas, Patrizia M. Flynn, Mark W. Kline

Research output: Contribution to journalArticlepeer-review

31 Scopus citations

Abstract

Background. This study determined the safety, pharmacokinetics, antiviral activity and immunologic effects of efavirenz liquid formulation, nelfinavir and nucleoside reverse transcriptase inhibitors (NRTIs) in HIV-infected children, 3 to 9 years of age. Methods. Plasma HIV-1 RNA and lymphocyte subsets were measured at various intervals after initiation of therapy. Pharmacokinetic studies were performed at Week 2, and doses of efavirenz and nelfinavir were adjusted if area under the curve values fell outside specified target ranges. Results. This combination of antiretrovirals was well-tolerated. Pharmacokinetic values were similar to those observed in a previous study of older children who received efavirenz capsules in combination with nelfinavir and NRTIs. After 48 weeks of therapy 63% of subjects had plasma HIV RNA levels of <400 copies/ml, and 58% had <50 copies/ml in an intent-to-treat analysis. CD4 cell count and percentage rose significantly over this time, whereas the number of activated CD8 cells declined. Conclusions. Combination therapy with efavirenz liquid formulation, nelfinavir and NRTIs is an attractive treatment option for HIV infected children >3 years of age who are unable to take efavirenz capsules.

Original languageEnglish (US)
Pages (from-to)659-663
Number of pages5
JournalPediatric Infectious Disease Journal
Volume21
Issue number7
DOIs
StatePublished - 2002

Keywords

  • Antiretroviral therapy
  • Efavirenz
  • Pediatric human immunodeficiency virus infection
  • Pharmacokinetics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

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