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
Cytomegalovirus Infections, HIV Infections
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Concurrent Medication: PER AMENDMENT 10/24/95: Allowed: All antiretroviral agents and other medications except those listed under Exclusion - Concurrent Medications. Didanosine. However, patients receiving both drugs (didanosine and ganciclovir) should be monitored for toxicity. Amphotericin B is allowed but requires additional monitoring. Patients must have: HIV infection. CMV infection. CD4 count < 150 cells/mm3 or < 15 percent AND/OR quiescent CMV disease. NO loss of sight from CMV retinitis. NO acute opportunistic infection. Life expectancy at least to study completion. Consent of parent or guardian. NOTE: Infants < 6 months of age at enrollment must have been >= 36 weeks gestational age at birth. NOTE: Patients may co-enroll in other ACTG protocols that do not involve the administration of disallowed medications. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Loss of sight in one eye for any reason, with evidence of CMV retinitis in the other eye. Acute or chronic diarrhea that would affect absorption. Clinical or laboratory toxicities of grade 3 or worse. Concurrent Medication: Excluded: Foscarnet. Acyclovir. Interferon. Myelotoxic agents for malignancy or other condition. Other agents with anti-CMV activity. (NOTE: Enrollment of patients on IVIG must be discussed with protocol chair.) Imipenem/cilastatin sodium. Prior Medication: Excluded within 30 days prior to study entry: G-CSF or GM-CSF.
Sites / Locations
- Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
- Usc La Nichd Crs
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- UCSD Maternal, Child, and Adolescent HIV CRS
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Colorado Denver NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Chicago Children's CRS
- Tulane/LSU Maternal/Child CRS
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
- Columbia IMPAACT CRS
- Incarnation Children's Ctr.
- NYU Med. Ctr., Dept. of Medicine
- St. Christopher's Hosp. for Children
- UW School of Medicine - CHRMC
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS