An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

Not Applicable

Completed

• Conditions: Cytomegalovirus Retinitis; HIV Infections

• Registration Number: NCT00002015
• Lead Sponsor: Roche Global Development

Brief Summary

To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). To determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir IV in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections.

Detailed Description

Not available

Study Timeline

• Status Verified: 1996-04
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

Univ of Rochester Med Ctr; 🇺🇸 Rochester, New York, United States

Ctr for the Health Sciences / UCLA Med Ctr; 🇺🇸 Los Angeles, California, United States

Univ of Chicago / Wylers; 🇺🇸 Chicago, Illinois, United States

Los Angeles County - USC Med Ctr; 🇺🇸 Los Angeles, California, United States

Univ of Nebraska Med Ctr; 🇺🇸 Omaha, Nebraska, United States

Univ of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Children's Hosp of Los Angeles; 🇺🇸 Los Angeles, California, United States

Baylor College of Medicine / Texas Children's Hosp; 🇺🇸 Houston, Texas, United States