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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections

Intervention: Fomivirsen sodium (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Isis Pharmaceuticals

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.

Clinical Details

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)

Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

UCI College of Medicine, Irvine, California 92715, United States

Retina - Vitreous Associates Med Group, Los Angeles, California 90017, United States

Community Eye Med Group, Pasadena, California 911052536, United States

San Diego Naval Hosp, San Diego, California 92134, United States

Univ of California San Francisco / SF Gen Hosp, San Francisco, California 94110, United States

Santa Clara Valley Med Ctr, San Jose, California 95128, United States

Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States

Dr Alan Palestine, Washington, District of Columbia 20036, United States

Dr Julio Perez, Fort Lauderdale, Florida 33060, United States

Bascon Palmer Eye Institute, Miami, Florida 33136, United States

Emory Univ School of Medicine / Emory Eye Ctr, Atlanta, Georgia 30322, United States

Georgia Retina, Atlanta, Georgia 30327, United States

Univ of Illinois, Chicago, Illinois 60612, United States

Indiana Univ Med Ctr, Indianapolis, Indiana 46202, United States

Tulane Univ, New Orleans, Louisiana 70112, United States

Vitreo - Retinal Consultants, New York, New York 10028, United States

Charlotte Eye Ear Nose & Throat Association, Charlotte, North Carolina 28204, United States

Duke Univ, Durham, North Carolina 27710, United States

Graduate Hosp, Philadelphia, Pennsylvania 191461192, United States

Hahnemann Univ Hosp, Philadelphia, Pennsylvania 19102, United States

Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 752359057, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Vitreoretinal Consultants, Houston, Texas 77004, United States

Virginia Eye Consultants, Norfolk, Virginia 23507, United States

Novum Inc, Seattle, Washington 98104, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 20, 2015

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