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    Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age

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    Authors
    Chadwick, Ellen Gould
    Rodman, John H.
    Britto, Paula
    Powell, Christine
    Palumbo, Paul
    Luzuriaga, Katherine
    Hughes, Michael
    Abrams, Elaine J.
    Flynn, Patricia M.
    Borkowsky, William
    Yogev, Ram
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    UMass Chan Affiliations
    Department of Pediatrics
    Document Type
    Journal Article
    Publication Date
    2005-09-01
    Keywords
    Age Factors
    Antiretroviral Therapy, Highly Active
    Child, Preschool
    Dose-Response Relationship, Drug
    Drug Administration Schedule
    Female
    Follow-Up Studies
    HIV Infections
    HIV-1
    Humans
    Infant
    Infant, Newborn
    Lamivudine
    Male
    Maximum Tolerated Dose
    Prospective Studies
    Risk Assessment
    Ritonavir
    Severity of Illness Index
    Single-Blind Method
    Survival Rate
    Treatment Outcome
    Zidovudine
    Immunology and Infectious Disease
    Pediatrics
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    Link to Full Text
    http://dx.doi.org/10.1097/01.inf.0000177281.93658.df
    Abstract
    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 /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.
    Source
    Pediatr Infect Dis J. 2005 Sep;24(9):793-800. DOI 10.1097/01.inf.0000177281.93658.df
    DOI
    10.1097/01.inf.0000177281.93658.df
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/43464
    PubMed ID
    16148846
    Related Resources
    Link to Article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1097/01.inf.0000177281.93658.df
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