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

Completed · Phase 2

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002356

Run by

Ionis Pharmaceuticals, Inc.

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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