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

Astra USA

Status: Completed

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Foscarnet sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002432

020E

89-FOS-06

Details and patient eligibility

About

To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of foscarnet maintenance therapy for treatment of AIDS patients experiencing CMV retinitis.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.