A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
Cytomegalovirus Retinitis, HIV Infections
About this trial
This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Ganciclovir, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy. ddI. ddC. Patients must have: Confirmed HIV infection or diagnosis of AIDS. CMV retinitis of no more than 4 months duration. Stable retinitis. Understanding of the nature of the study, agree to its provisions, and sign informed consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Persistent or clinically significant diarrhea (3 or more unformed stools/day), nausea, or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal disease. Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment. Ocular conditions requiring immediate surgical correction (e.g., retinal tear or detachment). Dementia, decreased mentation, or other encephalopathic signs and symptoms that would interfere with the ability of the subject to give informed consent or comply with the protocol. Concurrent Medication: Excluded: Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance therapy. Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected cytokines. Patients with the following prior conditions are excluded: Diagnosis of CMV retinitis more than 4 months prior to study entry. More than two prior induction treatments of IV ganciclovir (initial induction and one re-induction are permitted). Prior Medication: Excluded: More than two induction treatment regimens with IV ganciclovir. Prior oral ganciclovir (in Groups A, B, and C only).
Sites / Locations
- East Bay AIDS Ctr
- AIDS Clinical Research Ctr / UCLA Med Ctr
- UCSD Med Ctr / Pediatrics
- San Francisco Gen Hosp
- Davies Med Ctr / c/o HIV Institute
- Mount Zion Med Ctr
- Dr David Busch
- Georgetown Univ Med Ctr
- Miami Veterans Administration Med Ctr
- AIDS Research Consortium of Atlanta
- Margo Heath - Chiozzi
- Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
- Beth Israel Hosp
- Dr Dorothy Friedberg
- Cornell Univ Med College
- Buckley Braffman Stern Med Associates
- Oak Lawn Physicians Group
- Univ TX Galveston Med Branch
- Univ of Washington / Pacific Med Ctr
- Saint Paul's Hosp