On June 1, 2012, the PTN completed enrollment into its trial of the pharmacokinetics of acyclovir in infants.
Acyclovir is approved by the U.S. Food and Drug Administration for herpes simplex virus (HSV) infections in babies. HSV is a very serious infection in this vulnerable group, often resulting in death or profound mental retardation. To date, appropriate dosing of acyclovir has not been adequately studied in premature babies, meaning that doctors must make educated guesses about the dosing of this potentially life-saving drug.
In this study, we are administering acyclovir to premature babies with suspected HSV infections and determining the levels of acyclovir in each baby. This will allow us to determine the appropriate dose of acyclovir in this understudied population. A total of 20 babies <35 weeks gestation at birth and <45 days of age have been enrolled.
The PTN expects to have preliminary data from this trial available on this website by 2013.