The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
NCT ID: NCT00002356
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
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PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.
Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Fomivirsen sodium
Eligibility Criteria
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Inclusion Criteria
* AIDS.
* CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.
* Intolerance or resistance to other therapies.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Locations
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UCI College of Medicine
Irvine, California, United States
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 Alan Palestine
Washington D.C., District of Columbia, United States
Dr Julio Perez
Fort Lauderdale, Florida, United States
Bascon Palmer Eye Institute
Miami, Florida, United States
Emory Univ School of Medicine / Emory Eye Ctr
Atlanta, Georgia, United States
Georgia Retina
Atlanta, Georgia, United States
Univ of Illinois
Chicago, Illinois, United States
Indiana Univ Med Ctr
Indianapolis, Indiana, United States
Tulane Univ
New Orleans, Louisiana, United States
Vitreo - Retinal Consultants
New York, New York, United States
Charlotte Eye Ear Nose & Throat Association
Charlotte, North Carolina, United States
Duke Univ
Durham, 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
Vitreoretinal Consultants
Houston, 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
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Other Identifiers
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ISIS 2922-CS7
Identifier Type: -
Identifier Source: secondary_id
251C
Identifier Type: -
Identifier Source: org_study_id