A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
- Conditions
- Cytomegalovirus InfectionsHIV Infections
- Registration Number
- NCT00000805
- Brief Summary
PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral ganciclovir in HIV-infected infants, children, and adolescents.
SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV.
Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.
- Detailed Description
Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.
Patients are assigned to 1 of 5 (PER AMENDMENT 10/24/95, was 4) oral (syrup or capsules) dose levels following a single intravenous dose of ganciclovir. Treatment continues for 72 (PER AMENDMENT 10/24/95, was 24 weeks) weeks after the last patient has been enrolled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Incarnation Children's Ctr.
🇺🇸New York, New York, United States
Usc La Nichd Crs
🇺🇸Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Torrance, California, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
UW School of Medicine - CHRMC
🇺🇸Seattle, Washington, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
St. Joseph's Hosp. & Med. Ctr. of New Jersey
🇺🇸Paterson, New Jersey, United States
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
🇺🇸Los Angeles, California, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
St. Christopher's Hosp. for Children
🇺🇸Philadelphia, Pennsylvania, United States