Phase I Safety and Pharmacokinetics Study of Micronized Atovaquone in Human Immunodeficiency Virus-Infected Infants and Children

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Published inAntimicrobial Agents and Chemotherapy Vol. 42; no. 6; pp. 1315 - 1318
Main Authors HUGHES, W, DORENBAUM, A, SADLER, B, YOGEV, R, BEAUCHAMP, B, JING XU, MCNAMARA, J, MOYE, J, PURDUE, L, VAN DYKE, R, ROGERS, M
Format Journal Article
LanguageEnglish
Published Washington, DC American Society for Microbiology 01.06.1998
Subjects
AIDS-Related Opportunistic Infections
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antifungal Agents
Antiparasitic agents
Biological and medical sciences
Medical sciences
Naphthoquinones
Pharmacology
Pharmacology. Drug treatments
Human
Atovaquone
Toxicity
Single dose
Oral administration
Retroviridae
Infant
Pneumocystis carinii
Bioavailability
Lentivirus
Fungi
Virus
Infection
Antiprotozoal agent
Antibiotic
Parasiticid
Phase I trial
Fungi Imperfecti
Human immunodeficiency virus
Daily dose
Pharmacokinetics
Child
Thallophyta
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Abstract Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology.   For an alternate route to AAC .asm.org, visit: AAC       
AbstractList A phase I dose-escalating safety and pharmacokinetic study evaluated an oral suspension of micronized atovaquone (m-atovaquone) in infants and children stratified into age groups from 1 month to 12 years of age. Dosages of 10, 30, and 45 mg/kg of body weight/day were evaluated as single daily doses over a period of 12 days. Steady-state concentrations in plasma were determined on day 12, and single postdose concentrations were measured on days 1, 3, 5, 7, 9, 13, 15, 18, 21, and 24. Prior studies with adults suggest that the average plasma atovaquone concentration of 15 μg/ml is associated with therapeutic success in more than 95% of patients with Pneumocystis carinii pneumonitis. The results showed m-atovaquone to be safe and well tolerated. Dosages of 30 mg/kg/day were adequate to achieve an average steady-state concentration of greater than 15 μg/ml in children ages 1 to 3 months and 2 to 12 years, but a dosage of 45 mg/kg/day was needed to reach this concentration in infants 3 to 24 months of age. The oral suspension of atovaquone is safe and well tolerated in children. A single daily dose of 30 mg/kg provides bioavailability considered adequate for therapy of P. carinii pneumonia, but infants between 3 and 24 months of age may require a dosage of 45 mg/kg/day.
A phase I dose-escalating safety and pharmacokinetic study evaluated an oral suspension of micronized atovaquone (m-atovaquone) in infants and children stratified into age groups from 1 month to 12 years of age. Dosages of 10, 30, and 45 mg/kg of body weight/day were evaluated as single daily doses over a period of 12 days. Steady-state concentrations in plasma were determined on day 12, and single postdose concentrations were measured on days 1, 3, 5, 7, 9, 13, 15, 18, 21, and 24. Prior studies with adults suggest that the average plasma atovaquone concentration of 15 μg/ml is associated with therapeutic success in more than 95% of patients with Pneumocystis carinii pneumonitis. The results showed m-atovaquone to be safe and well tolerated. Dosages of 30 mg/kg/day were adequate to achieve an average steady-state concentration of greater than 15 μg/ml in children ages 1 to 3 months and 2 to 12 years, but a dosage of 45 mg/kg/day was needed to reach this concentration in infants 3 to 24 months of age. The oral suspension of atovaquone is safe and well tolerated in children. A single daily dose of 30 mg/kg provides bioavailability considered adequate for therapy of P. carinii pneumonia, but infants between 3 and 24 months of age may require a dosage of 45 mg/kg/day.
A phase I dose-escalating safety and pharmacokinetic study evaluated an oral suspension of micronized atovaquone (m-atovaquone) in infants and children stratified into age groups from 1 month to 12 years of age. Dosages of 10,30, and 45 mg/kg of body weight/day were evaluated as single daily doses over a period of 12 days. Steady-state concentrations in plasma were determined on day 12, and single postdose concentrations were measured on days 1, 3, 5, 7, 9, 13, 15, 18, 21, and 24. Prior studies with adults suggest that the average plasma atovaquone concentration of 15 mu g/ml is associated with therapeutic success in more than 95% of patients with Pneumocystis carinii pneumonitis. The results showed m-atovaquone to be safe and well tolerated. Dosages of 30 mg/kg/day were adequate to achieve an average steady-state concentration of greater than 15 mu g/ml in children ages 1 to 3 months and 2 to 12 years, but a dosage of 45 mg/kg/day was needed to reach this concentration in infants 3 to 24 months of age. The oral suspension of atovaquone is safe and well tolerated in children. A single daily dose of 30 mg/kg provides bioavailability considered adequate for therapy of P. carinii pneumonia, but infants between 3 and 24 months of age may require a dosage of 45 mg/kg/day.
Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology.   For an alternate route to AAC .asm.org, visit: AAC       
Author Lynette Purdue
Jing Xu
Russell van Dyke
Michael Rogers
Walter Hughes
Belinda Beauchamp
Ram Yogev
James McNamara
John Moye
Alejandro Dorenbaum
The Pediatric Aids Clinical Trials Group
Brian Sadler
AuthorAffiliation St. Jude Children’s Research Hospital, Memphis, Tennessee 1 ; University of California, San Francisco, California 2 ; Chicago Children’s Memorial Hospital, Chicago, Illinois 3 ; University of Puerto Rico, San Juan, Puerto Rico 4 ; Harvard Medical School, Boston, Massachusetts 5 ; National Institute of Allergy and Infectious Disease 6 and National Institute of Child Health and Human Development, 7 Bethesda, Maryland; Tulane University School of Medicine, New Orleans, Louisiana 8 ; Glaxo-Wellcome, Research Triangle Park, North Carolina 9 ; and the National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 10
AuthorAffiliation_xml – name: St. Jude Children’s Research Hospital, Memphis, Tennessee 1 ; University of California, San Francisco, California 2 ; Chicago Children’s Memorial Hospital, Chicago, Illinois 3 ; University of Puerto Rico, San Juan, Puerto Rico 4 ; Harvard Medical School, Boston, Massachusetts 5 ; National Institute of Allergy and Infectious Disease 6 and National Institute of Child Health and Human Development, 7 Bethesda, Maryland; Tulane University School of Medicine, New Orleans, Louisiana 8 ; Glaxo-Wellcome, Research Triangle Park, North Carolina 9 ; and the National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 10
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  surname: ROGERS
  fullname: ROGERS, M
  organization: National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, United States
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CitedBy_id crossref_primary_10_1111_jvim_14777
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Issue 6
Keywords Human
Atovaquone
Toxicity
Single dose
Oral administration
Retroviridae
Infant
Pneumocystis carinii
Bioavailability
Lentivirus
Fungi
Virus
Infection
Antiprotozoal agent
Antibiotic
Parasiticid
Phase I trial
Fungi Imperfecti
Human immunodeficiency virus
Daily dose
Pharmacokinetics
Child
Thallophyta
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Corresponding author. Mailing address: St. Jude Children’s Research Hospital, 332 N. Lauderdale, Memphis, TN 38105. Phone: (901) 495-3485. Fax: (901) 522-6616. E-mail: walter.hughes@stjude.org.
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PublicationTitle Antimicrobial Agents and Chemotherapy
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PublicationYear 1998
Publisher American Society for Microbiology
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A phase I dose-escalating safety and pharmacokinetic study evaluated an oral suspension of micronized atovaquone (m-atovaquone) in infants and children...
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SubjectTerms AIDS-Related Opportunistic Infections
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antifungal Agents
Antiparasitic agents
Biological and medical sciences
Medical sciences
Naphthoquinones
Pharmacology
Pharmacology. Drug treatments
Title Phase I Safety and Pharmacokinetics Study of Micronized Atovaquone in Human Immunodeficiency Virus-Infected Infants and Children
URI http://aac.asm.org/content/42/6/1315.abstract
https://journals.asm.org/doi/10.1128/AAC.42.6.1315
https://search.proquest.com/docview/16468213
https://pubmed.ncbi.nlm.nih.gov/PMC105594
Volume 42
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