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Home > "A" Clinical Trials Conditions > Assessment of valganciclovir in neonates with CMV  Assessment of valganciclovir in neonates with CMV
Assessment of valganciclovir in neonates with CMV
For Condition: Cytomegalovirus Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Primary: o To determine the pharmacokinetics of ganciclovir following administration of oral valganciclovir syrup in neonates and young infants with symptomatic congenital CMV disease o To identify a dose of valganciclovir to provide comparable ganciclovir plasma concentrations in neonates and young infants with symptomatic congenital CMV disease. Secondary: o To evaluate the safety and tolerability of valganciclovir syrup in the neonatal and infantile populations o To determine the pharmacodynamics of ganciclovir following administration of oral valganciclovir syrup in neonates and young infants with symptomatic congenital CMV disease.
Details: Recent trials have demonstrated that ganciclovir treatment of neonates with symptomatic congenital CMV disease involving the CNS results in improved hearing function (or maintenance of normal hearing function) and prevents hearing deterioration at 6 months. Furthermore, ganciclovir therapy may prevent hearing deterioration at �d 1 year. Ganciclovir recipients also have a more rapid resolution of their transaminase elevations and a greater degree of short term growth in weight and head circumference compared with untreated patients. Ganciclovir therapy must be administered intravenously and often requires the establishment of a central line in these babies. Valganciclovir, the oral prodrug of ganciclovir, has been developed as a syrup formulation and presents the opportunity to treat longer without the requirement for a central line, but pharmacokinetic data are needed in infants first to assure the correct dose is being utilized. This Phase I/II, multi-center, open-label trial will assess the safety/tolerability and pharmacokinetics (ganciclovir concentrations) following administration of oral valganciclovir to neonates with symptomatic congenital CMV disease. A total of 24 patients will be evaluated. Two different dose determination strategies will be applied in this protocol. The first is an individual patient approach. The second is a group dose modification strategy. The primary endpoint is pharmacokinetics of ganciclovir following administration of oral valganciclovir syrup. The pharmacokinetics will be assessed by a population approach to PK data analysis. Secondary endpoints are: the pharmacokinetics of valganciclovir following administration of oral valganciclovir; the correlation of ganciclovir plasma concentrations following intravenous ganciclovir or oral valganciclovir syrup with CMV whole blood viral load; the incidence of emesis following oral valganciclovir administration (tolerability); safety as assessed by neutropenia incidence.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Uncontrolled, Crossover Assignment
Minimum Age/Maximum Age: /1 Month
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Signed informed consent from parent(s) or legal guardian(s). - Culture confirmation of cytomegalovirus from urine or throat swab specimens. - Less than or equal to 30 days of age at study enrollment. - Weight at study enrollment > or equal to 1800 grams - Gestational age greater than or equal to 32 weeks. - - - � Symptomatic congenital CMV disease, as manifest by one or more of the following: - Thrombocytopenia - Petechiae - Hepatomegaly - Splenomegaly - Intrauterine growth restriction - Hepatitis (elevated transaminases and/or bilirubin - Central nervous system involvement of the CMV disease (such as microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal CSF indices for age, chorioretinitis, hearing deficits as detected by brainstem evoked response, and/or positive CMV PCR from CSF) EXCLUSION CRITERIA: - Imminent demise. - Patients receiving other antiviral agents or immune globulin. - Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis). - Creatinine clearance less than 10 mL/min at time of study enrollment. - Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).
Total Enrollment: 24
Location and Contact Information:
Thomas Jefferson University *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting
St. Louis University *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
University of Alberta *Recruiting*
Edmonton, Alberta, T6G2B7
Canada
Recruiting
Cook - Fort Worth Children's Medical Center *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting
Tulane University Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
University of Louisville Health Sciences Center *Recruiting*
Louisville, Kentucky, 40292
United States
Recruiting
State University New York Stony Brook *Recruiting*
Stony Brook, New York, 11794
United States
Recruiting
MetroHealth Medical Center of Cleveland *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting
University of Alabama at Birmingham (CASG) *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
Via Christi Regional Medical Center *Recruiting*
Wichita, Kansas, 67203
United States
Recruiting
University of Texas Southwestern Medical Center *Recruiting*
Dallas, Texas, 75235
United States
Recruiting
Arkansas Children's Hospital *Recruiting*
Little Rock, Arkansas, 72202
United States
Recruiting
University of Texas Hlth Sci Ctr San Ant *Recruiting*
San Antonio, Texas, 78284-78
United States
Recruiting
University of Florida HSC - Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting
University of Kansas *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting
University of Manitoba - Winnipeg *Recruiting*
Winnipeg, Manitoba, R3T 2N2
Canada
Recruiting
Additional Information:
Study ID Numbers: 01-595;
Study Start Date: July 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031434
Other Cytomegalovirus Infections Studies:
1. Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study
2. Infection and Cardiovascular Disease
3. A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
4. A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
5. Assessment of valganciclovir in neonates with CMV
Related Studies:
Other Cytomegalovirus Infections Clinical Trials
Other Kentucky Clinical Trials
Other Louisville Clinical Trials
Assessment of valganciclovir in neonates with CMV
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