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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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Los Angeles, California, United States
Usc La Nichd Crs
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Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
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Univ. of Colorado Denver NICHD CRS
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Univ. of Miami Ped. Perinatal HIV/AIDS CRS
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Chicago Children's CRS
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Tulane/LSU Maternal/Child CRS
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...and 9 more locations
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