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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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Infections |
Drug: ganciclovir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
| Estimated Enrollment: | 130 |
| Estimated Study Completion Date: | November 2005 |
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.
Eligibility| Ages Eligible for Study: | up to 1 Month |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00001100 History of Changes |
| Other Study ID Numbers: | DMID ARB-AL-91-CMV, DAB-AL-558607 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 26, 2010 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Ganciclovir |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013