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

HIV Infections Clinical Trial

Official title:

An Open-Label Study of the Safety and Efficacy of Intravitreal ISIS 2922 in Acquired Immune Deficiency Syndrome (AIDS) Patients With Cytomegalovirus Retinitis (NOTE: Restricted to Patients Who Rollover From Another Controlled ISIS 2922 Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002356
• Other study ID #: 251C
• Secondary ID: ISIS 2922-CS7
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Patients receive intravitreal injections of ISIS 2922 at doses of either 150 or 300 mcg, depending on CMV retinitis location and extent of retinal involvement. There is a 3-week Induction period followed by at least 18 weeks of Maintenance. Induction is given on days 1, 8, and 15, and Maintenance doses are given every 14 days, beginning on day 29.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Fomivirsen sodium

Locations

Country	Name	City	State
United States	Emory Univ School of Medicine / Emory Eye Ctr	Atlanta	Georgia
United States	Georgia Retina	Atlanta	Georgia
United States	Charlotte Eye Ear Nose & Throat Association	Charlotte	North Carolina
United States	Univ of Illinois	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Duke Univ	Durham	North Carolina
United States	Dr Julio Perez	Fort Lauderdale	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Vitreoretinal Consultants	Houston	Texas
United States	Indiana Univ Med Ctr	Indianapolis	Indiana
United States	UCI College of Medicine	Irvine	California
United States	Retina - Vitreous Associates Med Group	Los Angeles	California
United States	Bascon Palmer Eye Institute	Miami	Florida
United States	Tulane Univ	New Orleans	Louisiana
United States	Vitreo - Retinal Consultants	New York	New York
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Community Eye Med Group	Pasadena	California
United States	Graduate Hosp	Philadelphia	Pennsylvania
United States	Hahnemann Univ Hosp	Philadelphia	Pennsylvania
United States	San Diego Naval Hosp	San Diego	California
United States	Univ of California San Francisco / SF Gen Hosp	San Francisco	California
United States	Santa Clara Valley Med Ctr	San Jose	California
United States	Novum Inc	Seattle	Washington
United States	Dr Alan Palestine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,