| Safety and pharmacokinetics of nelfinavir during the second and third trimesters of pregnancy and postpartum. | |
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MedLine Citation:
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PMID: 22306587 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Purpose: Evaluate the safety, tolerability, and pharmacokinetics (PK) of nelfinavir during pregnancy and postpartum in HIV-infected women. Methods: Phase IV, non-randomized, open-label study of nelfinavir 625 mg tablets (1250 mg) in combination with lamivudine/zidovudine twice daily. Primary endpoint was treatment-related or possibly treatment-related gastrointestinal or hepatic adverse events (AEs). Selected maternal and infant outcomes were recorded. Frequent plasma samples were collected for PK studies during the 2nd and 3rd trimesters, and 6 weeks postpartum, to analyze total and free nelfinavir and M8 concentrations. Results: Sixteen HIV+ pregnant women were enrolled. Six mild treatment-related AEs and 3 serious AEs occurred; 1 serious AE (elevated AST) met the primary endpoint. Compared with 6 weeks postpartum, levels of total nelfinavir were reduced by 44% and 46%, total M8 by 82% and 83%, free nelfinavir by 48% and 39%, and free M8 by 83% and 79% in the 2nd and 3rd trimesters, respectively. At 6 weeks postpartum, 75% and 50% of subjects maintained HIV-1 RNA levels <400 and <50 copies/mL, respectively. All pregnancies resulted in live births without transmission in 15 infants. Conclusions: Nelfinavir in combination with lamivudine/zidovudine was generally well tolerated. Total and free nelfinavir and M8 exposure were reduced in late pregnancy. |
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Authors:
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A Fang; S R Valluri; M-J O'Sullivan; R Maupin; T Jones; I Delke; P Clax |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: HIV clinical trials Volume: 13 ISSN: 1528-4336 ISO Abbreviation: HIV Clin Trials Publication Date: 2012 Jan-Feb |
Date Detail:
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Created Date: 2012-02-06 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100936377 Medline TA: HIV Clin Trials Country: United States |
Other Details:
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Languages: eng Pagination: 46-59 Citation Subset: IM |
Affiliation:
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Pfizer Inc, New York, New York, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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