Completed

A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.

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What is being tested

ganciclovir

Drug
Who is being recruted

DNA Virus Infections+2

+ Herpesviridae Infections

+ Infections

Until 1 Months
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 27, 2010
Sourced from a government-validated database.Claim as a partner

The study will enroll 130 newborn infants 1 month of age or younger with CMV involving the CNS. Patients will be assigned randomly (like tossing a coin) to receive either DHPG or no study drug treatment. All babies in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including hearing and eye exams and developmental assessments, will be done periodically until the child reaches 5 years of age. The degree of improved hearing among surviving patients will be a primary measure of drug effectiveness.

NCT00001100
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 27, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 1 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsHerpesviridae InfectionsInfectionsVirus DiseasesCytomegalovirus Infections

Criteria

Inclusion Criteria: Infants may be eligible for this study if they: Were full term infants (at least 32 weeks gestation). Are 1 month of age or younger (preferably less than 2 weeks). Weighed at least 1,200 grams (2.5 lbs) at birth. Have confirmed cytomegalovirus. Have evidence of CMV infection of the CNS with or without evidence of other organ involvement. Exclusion Criteria: Infants will not be eligible for this study if they: Have concurrent bacterial infection. Have HIV infection. Have mild symptoms or no symptoms of CMV infection at birth. Have an abnormal brain development (hydranencephaly) or any devastating brain involvement.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

NIAID/DMID/CASG Central Unit

Birmingham, United StatesOpen NIAID/DMID/CASG Central Unit in Google Maps
CompletedOne Study Center