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

Launched by ASTRA USA · Aug 30, 2001

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Eligibility criteria

• • Inclusion Criteria
• Prior Medication:
• Allowed:
• • Ganciclovir (DHPG).
• • 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.