Acyclovir PK study is complete

The PTN open-label study to describe the pharmacokinetics (PK) of acyclovir in premature infants has concluded, with results recently published in the Pediatric Infectious Diseases Journal.

Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in infants. HSV is a very serious infection in those <6 months of age, often resulting in death or profound mental retardation. Appropriate dosing of acyclovir is known for adults and children but has not been adequately studied in full-term or premature neonates.

This study examined acyclovir levels in the blood of premature and term infants who were placed on the drug to treat a suspected HSV infection, thereby determining the appropriate dose in this vulnerable population. Investigators found that infant maturity as measured by post-menstrual age* is associated with the infant body’s ability to clear the drug; in short, they determined that less frequent dosing is needed in younger infants to achieve optimal therapeutic benefit.

The study was conducted at two sites — Duke University Medical Center in Durham, North Carolina, and Wesley Medical Center in Wichita, Kansas. Site teams headed by Robert Lenfestey (Duke) and Paula Delmore (Wesley) enrolled 32 patients over the 9-month study. Next steps will involve a retrospective analysis of data from infants who received high-dose acyclovir; this information will support proposed label changes submitted to the Food and Drug Administration for use of acyclovir in infants.

* Post-menstrual age is the time elapsed between the first day of the mother’s last menstrual period and the infant’s birth, plus the time elapsed since birth.

PTN acyclovir trial locks its database

On September 19, 2012, the PTN locked the database for its trial of the pharmacokinetics of acyclovir in infants. Database lock means that all clinical trial data have been reviewed, queries have been resolved and issues addressed, and the database cannot be altered in any way.

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, acyclovir was administered to premature babies with suspected HSV infections to determine the levels of drug in each baby. Such information 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 were enrolled.

The PTN expects to have preliminary data from this trial available on this website in 2013.

PTN Acyclovir Trial Completes Enrollment

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.