An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

Astra USA

Status: Completed

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Foscarnet sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002039

88-FOS-01

020A

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 three different foscarnet maintenance therapy regimens. To determine the pharmacokinetics of intermittent administration of foscarnet with or without concomitant administration of zidovudine (AZT).

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.
• Recurrent episode of cytomegalovirus (CMV) retinitis.

Concurrent Medication:

Excluded:

• Nephrotoxic drugs.

Patients with the following are excluded:

• Recurrent episode of cytomegalovirus (CMV) retinitis.
• 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:

• Ganciclovir for cytomegalovirus (CMV) retinitis.
• Foscarnet for CMV retinitis.

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.