Status:
TERMINATED
Asymptomatic Congenital CMV Treatment
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Congenital Cytomegalovirus Infection
Eligibility:
All Genders
1-30 years
Phase:
PHASE2
Brief Summary
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV)...
Detailed Description
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV)...
Eligibility Criteria
Inclusion
- Parent(s)/legal guardian(s) have signed informed consent documents\*
- Confirmation of cytomegalovirus (CMV) by urine polymerase chain reaction (PCR) testing
- Infant \</= 30 days of age at initiation of study drug
- Weight at study enrollment \>/= 1775 grams
- Gestational age \>/= 32 weeks at birth
- There is a screening informed consent for screening phase of study participation, and a treatment informed consent for treatment phase of study participation.
Exclusion
- Symptomatic congenital cytomegalovirus (CMV) disease\*
- Sensorineural hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response (abr)) of known etiology other than CMV
- Prior or current receipt of ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
- Maternal receipt of CMV hyperimmune globulin during pregnancy
- Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
- Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
- Infants known to be born to women who are HIV positive (HIV testing is not required for study entry)
- Current receipt of other investigational drugs
- Symptomatic disease is defined as one or more of the following: 1) thrombocytopenia, if known; 2) petechiae; 3) hepatomegaly; 4) splenomegaly; 5) intrauterine growth restriction; 6) hepatitis (elevated transaminases and/or direct bilirubin), if known; 7) central nervous system involvement of the CMV disease (such as microcephaly; radiographic abnormalities indicative of CMV CNS disease, if known; abnormal CSF indices for age, if known; chorioretinitis, if known; and/or positive CMV PCR from CSF, if known).
Key Trial Info
Start Date :
August 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03301415
Start Date
August 21 2019
End Date
November 5 2020
Last Update
January 26 2023
Active Locations (9)
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1
University of Alabama - Children's of Alabama - Clinical Virology
Birmingham, Alabama, United States, 35233-1711
2
Arkansas Children's Hospital - Infectious Diseases
Little Rock, Arkansas, United States, 72202
3
University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases
Louisville, Kentucky, United States, 40202
4
University of Mississippi - Children's Infectious Diseases
Jackson, Mississippi, United States, 39216-4505