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

Sponsor

Astra USA (Industry)

Overall Status

Completed

CT.gov ID

NCT00002039

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Foscarnet sodium	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.