A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following are excluded:
• •Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
• •Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
• •Known allergy to foscarnet.
• •Concurrent Medication:
• •Excluded:
• •Nephrotoxic drugs.
• •Acyclovir.
• •Patients with the following are excluded:
• •Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
• •Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
• •Known allergy to foscarnet.
• •Prior Medication:
• •Excluded within 7 days of study entry:
• •Immunomodulators.
• •Biologic response modifiers.
• •Investigational agents (other than ganciclovir).
• •Patients with AIDS as defined by the CDC, with manifest first episode cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.
• •Patients must be able to give informed consent.
• •Patients who enter the study because of ganciclovir toxicity will have received ganciclovir therapy which resulted in either absolute neutrophil count falling to \< 750 cells/mm3 or platelet count falling to \< 50000 platelets/mm3 on two separate occasions during either:
• •A ganciclovir induction regimen of 7.5 mg (or more)/kg/day in divided doses.
• •A maintenance regimen of 5 mg (or more)/kg/day as a single daily dose.
• •Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria:
• •CMV retinitis progression has occurred either 1) at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10 mg/kg/day in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 mg (or more)/kg/day, at least 5 days/week) where maintenance therapy began within 1 week of completing induction therapy.