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

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Disease Information

Descriptive Information
Brief Title † The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
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)
Brief 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.
Detailed 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.
Study Phase Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Cytomegalovirus Retinitis HIV Infections
Intervention † DrugFomivirsen sodium
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment †
Start Date †
Completion Date
Primary Completion Date
Eligibility 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.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00002356
Organization ID 251C
Secondary IDs †† ISIS 2922-CS7
Responsible Party
Study Sponsor † Isis Pharmaceuticals
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date December 1998
First Received Date † November 2, 1999
Last Updated Date June 23, 2005
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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