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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002356

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: December 1998

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
Official Title ^ICMJE	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 Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Fomivirsen sodium
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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 and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002356
Other Study ID Numbers ^ICMJE	251C, ISIS 2922-CS7
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Isis Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1998
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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