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.