A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

NCT ID: NCT00002156

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL

Brief Summary

To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.

Detailed Description

In Stage 1 of the study, 20 patients receive one of two doses of ISIS 2922 on days 1, 8, and 15 (Induction) then every 14 days (maintenance), with ganciclovir given daily during both Induction and Maintenance. Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose (day 29). In Stage 2 of the study, 174 patients are randomized to receive either a) ISIS 2922 at the dose established in Stage 1 on days 1, 8, and 15 and then every 14 days, with ganciclovir given daily during both Induction and Maintenance, or b) ganciclovir daily for 14 consecutive days and then a lower dose as maintenance. Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

Conditions

Cytomegalovirus Retinitis; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Fomivirsen sodium

Intervention Type: DRUG

Ganciclovir

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients must have:

• AIDS.
• CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
• No more than one previous progression of CMV retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions in the eye to be treated are excluded:

• External ocular infection.
• Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
• Ocular condition that will obstruct visualization of the posterior ocular structures.
• Retinal detachment.
• Silicone oil in eye.

Patients with the following other symptoms or conditions are excluded:

• Known or suspected allergy to phosphorothioate oligonucleotides.
• Syphilis.
• Retinal pigment epithelial stippling not associated with CMV retinitis.
• Pseudoretinitis pigmentosa.
• Chronic diarrhea that would impair absorption of oral ganciclovir.
• Intolerance to ganciclovir.

Concurrent Medication:

Excluded:

• Foscarnet or other anti-CMV agents other than ganciclovir.
• Mellaril.
• Stelazine.
• Thorazine.
• Clofazimine.
• Ethambutol/fluconazole combination.
• Investigational medications for CMV retinitis.

Concurrent Treatment:

Excluded:

• Investigational procedures 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 intolerance to ISIS 2922.

Prior Medication:

Excluded:

• Prior ganciclovir implant for CMV retinitis.
• More than 4 months of prior ganciclovir.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ionis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Locations

Retina - Vitreous Associates Med Group

Los Angeles, California, United States

Community Eye Med Group

Pasadena, California, 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

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Dr Julio Perez

Fort Lauderdale, Florida, United States

Georgia Retina

Atlanta, Georgia, United States

Univ of Illinois

Chicago, Illinois, United States

Indiana Univ Med Ctr

Indianapolis, Indiana, United States

Vitreo - Retinal Consultants

New York, New York, United States

Charlotte Eye Ear Nose and Throat Association

Charlotte, North Carolina, United States

Hahnemann Univ Hosp

Philadelphia, Pennsylvania, United States

Graduate Hosp

Philadelphia, Pennsylvania, United States

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Virginia Eye Consultants

Norfolk, Virginia, United States

Novum Inc

Seattle, Washington, United States

Countries

United States

Other Identifiers

ISIS 2922-CS3

Identifier Type: -

Identifier Source: secondary_id

251B

Identifier Type: -

Identifier Source: org_study_id