Document Detail

Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team.
MedLine Citation:
PMID:  9697716     Owner:  NLM     Status:  MEDLINE    
The safety, toxicity, and pharmacokinetics of intrapartum and early newborn nevirapine were evaluated in 17 human immunodeficiency virus type 1-infected women in labor and their newborns. No adverse effects of nevirapine were noted in any study mothers or infants. Following maternal dosing with 200 mg during labor, concentrations exceeding 100 ng/mL (10 times the in vitro IC50) were achieved in the newborns. Nevirapine elimination was prolonged in both mothers and infants, with median half-lives ranging from 36.8 to 65.7 h. Administration of 200 mg orally to the mothers in labor and of a single 2-mg/kg oral dose to the infants at 48-72 h after birth maintained serum concentrations in the infants > 100 ng/mL through 7 days of life.
M Mirochnick; T Fenton; P Gagnier; J Pav; M Gwynne; S Siminski; R S Sperling; K Beckerman; E Jimenez; R Yogev; S A Spector; J L Sullivan
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The Journal of infectious diseases     Volume:  178     ISSN:  0022-1899     ISO Abbreviation:  J. Infect. Dis.     Publication Date:  1998 Aug 
Date Detail:
Created Date:  1998-09-04     Completed Date:  1998-09-04     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0413675     Medline TA:  J Infect Dis     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  368-74     Citation Subset:  AIM; IM; X    
Department of Pediatrics, Boston Medical Center, Massachusetts 02118, USA.
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MeSH Terms
Anti-HIV Agents / adverse effects,  pharmacokinetics*,  therapeutic use
Cohort Studies
Follow-Up Studies
HIV Infections / drug therapy*
Infant, Newborn
Nevirapine / adverse effects,  pharmacokinetics*,  therapeutic use
Pregnancy Complications, Infectious / drug therapy*
Reverse Transcriptase Inhibitors / adverse effects,  pharmacokinetics*,  therapeutic use
Reg. No./Substance:
0/Anti-HIV Agents; 0/Reverse Transcriptase Inhibitors; 129618-40-2/Nevirapine

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

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