A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Have Not Had Success With Ganciclovir

Launched by ASTRA USA · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Ganciclovir.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following are excluded:
• • Known allergy to foscarnet.
• • 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 in patients with cytomegalovirus (CMV) retinitis.
• Concurrent Medication:
• Excluded:
• • Acyclovir.
• • Nephrotoxic agent.
• Patients with the following are excluded:
• • Known allergy to foscarnet.
• • 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 in patients with CMV retinitis.
• Prior Medication:
• Excluded within 7 days of study entry:
• • Immunomodulators.
• • Biologic response modifiers.
• • Investigational agents.
• AIDS patients experiencing cytomegalovirus (CMV) retinitis may be enrolled if they meet one of the following criteria:
• * Myelosuppression:
• • Previously suffered severe dose-limiting ganciclovir-related myelosuppression, or are ineligible for ganciclovir treatment due to myelosuppression.
• * Ganciclovir treatment failure:
• • Clearly failed to have a therapeutic response to ganciclovir therapy.
• • Patients must be able to give informed consent.
• • Patients presenting with a baseline absolute neutrophil count \< 750 cells/mm3 or baseline platelet count \< 50000 platelets/mm3 will be categorized as ineligible to receive ganciclovir induction therapy and will be allowed to enter the study.
• • 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
• • 1) a ganciclovir induction regimen of 7.5 mg or less ganciclovir/kg/day in divided doses or 2) a maintenance regimen of 5 mg or less ganciclovir/kg/day as a single dose.
• * Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria:
• • 1) CMV retinitis progression as defined in section V.C.1., i.e., has occurred either at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10.0 mg/kg/day in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 or more mg/kg/day in at least 5 days/week) where maintenance therapy began within
• • 1. week of completing induction therapy.