Document Detail


Infant safety during and after maternal valacyclovir therapy in conjunction with antiretroviral HIV-1 prophylaxis in a randomized clinical trial.
MedLine Citation:
PMID:  22509337     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Maternal administration of the acyclovir prodrug valacyclovir is compatible with pregnancy and breastfeeding. However, the safety profile of prolonged infant and maternal exposure to acyclovir in the context of antiretrovirals (ARVs) for prevention of mother-to-child HIV-1 transmission (PMTCT) has not been described.
METHODS: Pregnant Kenyan women co-infected with HIV-1/HSV-2 with CD4 counts > 250 cells/mm(3) were enrolled at 34 weeks gestation and randomized to twice daily 500 mg valacyclovir or placebo until 12 months postpartum. Women received zidovudine from 28 weeks gestation and single dose nevirapine was given to women and infants at the time of delivery for PMTCT. Infant blood was collected at 6 weeks for creatinine and ALT. Breast milk specimens were collected at 2 weeks postpartum from 71 women in the valacyclovir arm; acyclovir levels were determined for a random sample of 44 (62%) specimens. Fisher's Exact and Wilcoxon rank-sum tests were used for analysis.
RESULTS: One hundred forty-eight women were randomized and 146 mother-infant pairs were followed postpartum. PMTCT ARVs were administered to 98% of infants and all mothers. Valacyclovir was not associated with infant or maternal toxicities or adverse events, and no congenital malformations were observed. Infant creatinine levels were all normal (< 0.83 mg/dl) and median creatinine (median 0.50 mg/dl) and infant growth did not differ between study arms. Acyclovir was detected in 35 (80%) of 44 breast milk samples collected at 2 weeks postpartum. Median and maximum acyclovir levels were 2.62 and 10.15 mg/ml, respectively (interquartile range 0.6-4.19).
CONCLUSIONS: Exposure to PMTCT ARVs and acyclovir after maternal administration of valacyclovir during pregnancy and postpartum to women co-infected with HIV-1/HSV-2 was not associated with an increase in infant or maternal toxicities or adverse events.
TRIAL REGISTRATION: ClinicalTrials.gov NCT00530777.
Authors:
Alison L Drake; Alison C Roxby; James Kiarie; Barbra A Richardson; Anna Wald; Grace John-Stewart; Carey Farquhar
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-04-11
Journal Detail:
Title:  PloS one     Volume:  7     ISSN:  1932-6203     ISO Abbreviation:  PLoS ONE     Publication Date:  2012  
Date Detail:
Created Date:  2012-04-17     Completed Date:  2012-08-20     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  101285081     Medline TA:  PLoS One     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e34635     Citation Subset:  IM    
Affiliation:
Department of Global Health, University of Washington, Seattle, Washington, United States of America. adrake2@uw.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00530777
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MeSH Terms
Descriptor/Qualifier:
Acyclovir / adverse effects,  analogs & derivatives*,  pharmacology,  therapeutic use
Adult
Anti-HIV Agents / adverse effects*,  pharmacology,  therapeutic use*
Coinfection / transmission
Drug Toxicity*
Female
HIV Infections / drug therapy*,  prevention & control,  transmission
HIV-1 / drug effects
Herpesvirus 2, Human / drug effects
Humans
Infant
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Milk, Human / chemistry
Mothers*
Postpartum Period / drug effects
Pregnancy
Prenatal Exposure Delayed Effects* / chemically induced
Time Factors
Valine / adverse effects,  analogs & derivatives*,  pharmacology,  therapeutic use
Young Adult
Grant Support
ID/Acronym/Agency:
D43-TW00007/TW/FIC NIH HHS; K24 AI071113/AI/NIAID NIH HHS; K24 AI087399/AI/NIAID NIH HHS; K24 AI087399/AI/NIAID NIH HHS; K24 HD054314/HD/NICHD NIH HHS; P01 AI30731/AI/NIAID NIH HHS; P30 AI027757/AI/NIAID NIH HHS; P30 AI027757/AI/NIAID NIH HHS; R03 HD057773/HD/NICHD NIH HHS; R03 HD057773/HD/NICHD NIH HHS; R03 HD057773-02S1/HD/NICHD NIH HHS; R24 TW007988/TW/FIC NIH HHS; R24 TW007988/TW/FIC NIH HHS; T32 AI0714032/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 59277-89-3/Acyclovir; 7004-03-7/Valine; MZ1IW7Q79D/valacyclovir
Comments/Corrections

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