Pharmacokinetics and Safety of Stavudine in HIV‐Infected Pregnant Women and Their Infants: Pediatric AIDS Clinical Trials Group Protocol 332

Harvard University, Cambridge, Massachusetts, United States
The Journal of Infectious Diseases (Impact Factor: 6). 01/2005; 190(12):2167-74. DOI: 10.1086/425903
Source: PubMed


This study evaluates the safety, tolerance, and pharmacokinetics of stavudine (d4T) in humanimmunodeficiency virus (HIV)-infected
zidovudine (ZDV)-intolerant/refusing pregnant women and of single-dose d4T in their infants.Women received d4T and lamivudine
(3TC) from enrollment until labor. During labor, women received oral 3TC and either intravenous or oral d4T. Infants received
ZDV and 3TC for 6 weeks and a single dose of oral d4T at weeks 1 and 6. Mean maternal antenatal d4T pharmacokinetics (terminal
plasma half-life [T1/2], 83.5±16.8 min; area under the plasma-concentration time curve [AUC0-∞], 81.6±22.0 εg7min/mL; n = 6) were not significantly different from those during labor (T1/2, min; AUC0-∞87.3±24.7 , 88.1±16.6 εg7min/ mL; n = 6). Umbilical-cord and maternal plasma concentrations were not significantly different from one another. The oral clearance
of d4T in infants was significantly greater at week 6 versus week 1 (6.8±1.0 vs. 5.6±1.2 mL/min/kg). There were no toxicities,
in women or infants, that required discontinuation or modification of the study drug. No infants had positive HIV viral diagnostic
tests. d4T with or without 3TC is a potential alternative to ZDV for HIV-infected pregnant women.

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Available from: Lynne M Mofenson, Sep 17, 2014
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