DMID 11-0067  Ganciclovir in Premature Infants

Evaluation of the Pharmacokinetics and Pharmacodynamics of Ganciclovir in Premature Infants Receiving Treatment for Cytomegalovirus Infection [Pediatric study—15 sites]  

This is not a treatment study. It is a study to learn about what is the safest and correct dose of a medicine called IV Ganciclovir that is used to treat congenital Cytomegalovirus (CMV) Infection in premature babies. Congenital means that it occurred before birth. This medicine is given through an IV and is ordered by your primary doctor. This medicine has been studied in adults, in children and in babies who are not premature. We want to know how to treat premature babies safely. We are enrolling premature babies who have already been diagnosed with CMV infection, and whose doctor has already decided to treat them with IV Ganciclovir. We will study levels of the medicine in the blood while the baby is on treatment to determine the safest and best dose for premature babies.



DMID 11-0069 Valgan Toddler

A Phase II Randomized and Controlled Investigation of Six Weeks of Oral Valganciclovir Therapy in Infants and Children with Congenital Cytomegalovirus Infection and Hearing Loss  [Pediatric study—17 sites] 

This is a study for children who have been diagnosed with hearing loss in one or both ears in the past 12 weeks and may have an infection called congenital Cytomegalovirus (CMV). Congenital means that it occurred before birth. The purpose of this study is to compare the effect on hearing and neurological outcomes of infants between 1 month and 4 years of age who receive 6 weeks of Valganciclovir with children who do not receive this drug. We also want to learn about the safety of giving Valganciclovir to these babies and children. At this time, there is no standard of care for doctors to use to treat children for hearing loss because of a virus. 



DMID 11-0070 GeneXpert

Identification of Herpes Simplex Virus (HSV) Shedding In The Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Standard PCR, and Culture  [Pediatric study—15 sites]  

The Genexpert study began with the first subject enrolled on 29 April 2014. Investigational research teams have almost completely enrolled the study. There are less than 450 subjects needed to complete the protocol target enrollment of 12,500. Eight investigators are actively recruiting for subjects. The current funding cycle ends 9/2017 although an extension to 9/2018 is expected.



DMID 11-0071 BK Natural History Study

Natural History of Infection Caused by BK Virus (and other Opportunistic Viral Pathogens) in Renal and Renal-Pancreas Transplant Recipients  

The BK viremia natural history study enrolled first subject on 5 Feb 2015. Three sites are actively recruiting for subjects. There are 234 subjects enrolled. There are about 33 subjects identified with BK viremia based on plasma BK viral load by PCR. The investigators participating in this study are continuing recruitment for potential subjects. The projected total enrollment number is 450 subjects. The current funding cycle ends 9/2017 with an extension to 9/2018 expected.


DMID 16-0061 Neonatal HSV Observational Study

An Observational Study of Acyclovir Pharmacokinetics, Viral Population Kinetics, and Potential Biomarkers of Disease Severity in Neonatal Herpes Simplex Virus Infections

This is an observational study, not a treatment study. The purpose of this study is to learn more about how to best diagnose babies with HSV (Herpes Simplex Virus) infections, and also how babies respond to the standard treatment for this infection. We will screen babies who are suspected of having an HSV infection and have come to the emergency room or the hospital for this kind of evaluation and testing. We will be enrolling babies that are < 42 days old.


DMID 16-0095  Asymptomatic CMV Treatment Study

A Phase II, Single-Stage, Single-Arm Investigation of Oral Valganciclovir Therapy in Infants with Asymptomatic Congenital Cytomegalovirus Infection

The purpose of this study is to evaluate if using Valganciclovir as a treatment to prevent sensorineural hearing loss in babies born with an infection called congenital Cytomegalovirus (CMV) is helpful. Congenital means that it occurred before birth. We are looking for babies who were born with no outward symptoms (asymptomatic) of this infection and were not tested at birth. Valganciclovir is the approved drug that doctors currently use for the treatment of congenital CMV infection. This drug is used in babies born with outward symptoms (symptomatic) and who have had a confirmed positive CMV test done after delivery. Valganciclovir has been shown in earlier studies to be effective in preventing hearing loss or hearing deterioration in babies with symptomatic CMV disease.