The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922 therapy on another controlled clinical trial.

PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Treatments: Fomivirsen

Criteria

Inclusion Criteria

Patients must have:

• AIDS.

• CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.

• Intolerance or resistance to other therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Eligibility to participate in a controlled clinical trial of ISIS 2922.

• External ocular infection in eye to be treated.

• Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated.

• Ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated.

• Retinal detachment in eye to be treated.

• Known or suspected allergy to phosphorothioate oligonucleotides.

• Silicone oil in eye to be treated.

• Syphilis.

• Clinical evidence of retinal pigment epithelial stippling.

• Pseudoretinitis pigmentosa.

Concurrent Medication:

Excluded:

• Foscarnet.

• Mellaril, Stelazine, Thorazine, and Clofazimine.

• Ethambutol / fluconazole combination.

• Other investigational drugs for CMV retinitis.

Patients with the following prior conditions are excluded:

• History of surgery to correct retinal detachment in eye to be treated.

• History of ganciclovir implant for treatment of CMV retinitis.

• History of intolerance to ISIS 2922.

• History of syphilis.

Required:

• Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922.