A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

HIV Infections Clinical Trial

Official title:

A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002187
• Other study ID #: 251D
• Secondary ID: ISIS 2922-CS9
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis

Description:

This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Oral ganciclovir.

• Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia.

Patients must have:

• Documented AIDS.

• Clinical diagnosis of advanced CMV retinitis in 1 or both eyes.

• >= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.

• > 25% retinal involvement with CMV retinitis.

• Baseline CMV retinitis lesions which have leading edges > 1000 micrograms from the macula or optic disk.

Prior Medication:

Required:

• >= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.

Allowed:

• All anti-CMV therapies other than ganciclovir must be discontinued no less than 2 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• External ocular infection in the eye to be treated.

• Other herpetic infections of the retina, toxoplasma, retinochoroiditis, or other disease of the fundus that would preclude assessment of CMV retinitis in the eye to be treated.

• Ocular conditions that will obstruct visualization of the posterior ocular structures on the eye to be treated.

• Retinal detachment in the eye to be treated.

• Ganciclovir implant in the eye to be treated.

• Known or suspected allergy to phosphorothioate oligonucleotides or intolerance of ISIS 2922.

• Silicone oil in the eye to be treated.

• Pseudoretinitis pigmentosa.

• Syphilis.

Patients with the following prior conditions are excluded:

• History of surgery to correct retinal detachment in the eye to be treated.

• History of syphilis.

1. Systemic anti-CMV therapies other than oral ganciclovir.

• Mellaril, Stelazine, chlorpromazine and clofazimine.

• Combination use of ethambutol and fluconazole.

• Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated.

• Ganciclovir implant delivery device in the eye to be treated.

• Ganciclovir other than oral.

• Foscarnet.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Fomivirsen sodium

Locations

Country	Name	City	State
United States	Georgia Retina	Atlanta	Georgia
United States	Charlotte Eye Ear Nose & Throat Association	Charlotte	North Carolina
United States	Chicago Ctr for Clinical Research	Chicago	Illinois
United States	Univ of Illinois	Chicago	Illinois
United States	Duke Univ	Durham	North Carolina
United States	Dr Julio Perez	Fort Lauderdale	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana Univ Med Ctr	Indianapolis	Indiana
United States	Retina - Vitreous Associates Med Group	Los Angeles	California
United States	New York Univ Med Ctr	New York	New York
United States	Vitreo - Retinal Consultants	New York	New York
United States	Community Eye Med Group	Pasadena	California
United States	Hahnemann Univ Hosp	Philadelphia	Pennsylvania
United States	Dr Jacob Lalezari	San Francisco	California
United States	Univ of California San Francisco / SF Gen Hosp	San Francisco	California
United States	Novum Inc	Seattle	Washington
United States	Dr Alan Palestine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

New CMV drug won't replace other therapies. AIDS Alert. 1998 Nov;13(11):124-6. — View Citation

Roehr B. Fomivirsen approved for CMV retinitis. J Int Assoc Physicians AIDS Care. 1998 Oct;4(10):14-6. — View Citation