Document Detail


Design of antiretroviral clinical trials for HIV-1 infected pregnant women and their newborn infants.
MedLine Citation:
PMID:  11453614     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Antiretroviral therapy has been highly successful in reducing mother to child transmission of human immunodeficiency virus-1 infection in pregnant women. However, the treatment regimens are intensive, difficult to deliver in less developed countries, and there are limited pharmacology studies addressing critical questions regarding maternal safety and fetal risk. There are currently 3 pharmacologically diverse classes of antiretroviral agents with inadequate information available to define drug disposition necessary to determine appropriate dose regimens and limited data on long-term adverse events. This article summarizes representative clinical studies for selected antiretrovirals that provide a framework for continuing the necessary clinical research to extend successful outcomes in developed countries to human immunodeficiency virus-1 infected pregnant women and infants world-wide and minimize the risk of long-term adverse effects.
Authors:
J H Rodman
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.; Review    
Journal Detail:
Title:  Seminars in perinatology     Volume:  25     ISSN:  0146-0005     ISO Abbreviation:  Semin. Perinatol.     Publication Date:  2001 Jun 
Date Detail:
Created Date:  2001-07-16     Completed Date:  2001-12-07     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  7801132     Medline TA:  Semin Perinatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  170-6     Citation Subset:  IM    
Affiliation:
Department of Pharmaceutical Sciences, St Jude Children's Research Hospital, Memphis, TN 38105-2794, USA. john.rodman@stjude.org
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MeSH Terms
Descriptor/Qualifier:
Acquired Immunodeficiency Syndrome / drug therapy*,  prevention & control,  transmission*
Anti-HIV Agents / adverse effects*,  pharmacokinetics,  therapeutic use*
Clinical Trials as Topic*
Female
Fetus / drug effects
Humans
Infant, Newborn
Infectious Disease Transmission, Vertical
Pregnancy
Pregnancy Complications, Infectious / virology*
Grant Support
ID/Acronym/Agency:
AI-27562/AI/NIAID NIH HHS; AI-32908/AI/NIAID NIH HHS; AI-39191/AI/NIAID NIH HHS; CA-21765/CA/NCI NIH HHS; RR-11126/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents

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