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.

NCT ID: NCT00001100

Last Updated: 2010-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-11-30

Brief Summary

The purpose of this study is to evaluate the benefits and safety of the antiviral drug ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body, resulting in death in 10-30% of babies with symptoms of CMV. It can cause severe brain damage in a large percentage of surviving babies. Children in this study have a CMV infection of the central nervous system (CNS).

Detailed Description

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.

Conditions

Cytomegalovirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ganciclovir

Intervention Type: DRUG

Eligibility 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.

• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Locations

NIAID/DMID/CASG Central Unit

Birmingham, Alabama, United States

Countries

United States

References

Oliver SE, Cloud GA, Sanchez PJ, Demmler GJ, Dankner W, Shelton M, Jacobs RF, Vaudry W, Pass RF, Soong SJ, Whitley RJ, Kimberlin DW; National Institute of Allergy, Infectious Diseases Collaborative Antiviral Study Group. Neurodevelopmental outcomes following ganciclovir therapy in symptomatic congenital cytomegalovirus infections involving the central nervous system. J Clin Virol. 2009 Dec;46 Suppl 4(Suppl 4):S22-6. doi: 10.1016/j.jcv.2009.08.012. Epub 2009 Sep 18.

Reference Type: DERIVED

PMID: 19766534 (View on PubMed)

Other Identifiers

DAB-AL-558607

Identifier Type: -

Identifier Source: secondary_id

DMID ARB-AL-91-CMV

Identifier Type: -

Identifier Source: org_study_id