Document Detail

Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age.
MedLine Citation:
PMID:  16148846     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Few data are available regarding clinical outcomes or dosing requirements for the protease inhibitor ritonavir in human immunodeficiency virus (HIV)-infected children younger than under 24 months of age. METHODS: This prospective, multicenter phase I/II open label treatment trial used ritonavir, zidovudine and lamivudine to treat protease inhibitor-naive, HIV-infected infants between the ages of 4 weeks and 24 months. Two sequential dosing cohorts were treated with 350 or 450 mg/m(2) ritonavir every 12 hours; this report includes results of pharmacokinetics, safety, tolerability and efficacy through 104 weeks of follow-up of all subjects. RESULTS: Fifty HIV-infected children were treated. By week 16, 36 had achieved HIV-1 RNA <400 copies/mL (72% intent-to-treat, 84% as-treated analysis); by week 104, 18 maintained durable viral suppression (36% intent-to-treat, 46% as-treated). Poor medication adherence by caregiver report contributed to virologic failure. Few subjects experienced treatment-limiting toxicity: emesis or ritonavir refusal in 6 (12%); and severe but reversible anemia or elevated serum hepatic transaminases in 1 (4%) each. Apparent oral clearance was higher and the median predose concentrations were substantially lower than those found in adults. Median z scores for weight and height for age/gender were below normal at baseline but improved by week 104. CONCLUSIONS: A combination regimen of ritonavir, zidovudine and lamivudine was generally safe and produced sustained viral suppression in more than one-third of infants who initiated therapy before 2 years of age. Improved palatability of liquid preparations of protease inhibitors, supporting infrastructure and behavioral approaches to improve medication adherence with antiretrovirals will likely be necessary to further improve efficacy.
Ellen Gould Chadwick; John H Rodman; Paula Britto; Christine Powell; Paul Palumbo; Katherine Luzuriaga; Michael Hughes; Elaine J Abrams; Patricia M Flynn; William Borkowsky; Ram Yogev;
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  24     ISSN:  0891-3668     ISO Abbreviation:  Pediatr. Infect. Dis. J.     Publication Date:  2005 Sep 
Date Detail:
Created Date:  2005-09-08     Completed Date:  2006-01-06     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  793-800     Citation Subset:  IM    
Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
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MeSH Terms
Age Factors
Antiretroviral Therapy, Highly Active / adverse effects,  methods*
Child, Preschool
Dose-Response Relationship, Drug
Drug Administration Schedule
Follow-Up Studies
HIV Infections / congenital*,  drug therapy*,  mortality,  physiopathology
HIV-1 / drug effects*,  isolation & purification
Infant, Newborn
Lamivudine / administration & dosage,  pharmacokinetics
Maximum Tolerated Dose
Prospective Studies
Risk Assessment
Ritonavir / administration & dosage*,  pharmacokinetics*
Severity of Illness Index
Single-Blind Method
Survival Rate
Treatment Outcome
Zidovudine / administration & dosage,  pharmacokinetics
Reg. No./Substance:
0/Ritonavir; 134678-17-4/Lamivudine; 30516-87-1/Zidovudine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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