A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

HIV Infections Clinical Trial

Official title:

A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002156
• Other study ID #: 251B
• Secondary ID: ISIS 2922-CS3
• Status: Completed
• Phase: Phase 2
• 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

To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.

Description:

In Stage 1 of the study, 20 patients receive one of two doses of ISIS 2922 on days 1, 8, and 15 (Induction) then every 14 days (maintenance), with ganciclovir given daily during both Induction and Maintenance. Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose (day 29). In Stage 2 of the study, 174 patients are randomized to receive either a) ISIS 2922 at the dose established in Stage 1 on days 1, 8, and 15 and then every 14 days, with ganciclovir given daily during both Induction and Maintenance, or b) ganciclovir daily for 14 consecutive days and then a lower dose as maintenance. Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients must have:

• AIDS.

• CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).

• No more than one previous progression of CMV retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions in the eye to be treated are excluded:

• External ocular infection.

• Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.

• Ocular condition that will obstruct visualization of the posterior ocular structures.

• Retinal detachment.

• Silicone oil in eye.

Patients with the following other symptoms or conditions are excluded:

• Known or suspected allergy to phosphorothioate oligonucleotides.

• Syphilis.

• Retinal pigment epithelial stippling not associated with CMV retinitis.

• Pseudoretinitis pigmentosa.

• Chronic diarrhea that would impair absorption of oral ganciclovir.

• Intolerance to ganciclovir.

Concurrent Medication:

Excluded:

• Foscarnet or other anti-CMV agents other than ganciclovir.

• Mellaril.

• Stelazine.

• Thorazine.

• Clofazimine.

• Ethambutol/fluconazole combination.

• Investigational medications for CMV retinitis.

Concurrent Treatment:

Excluded:

• Investigational procedures 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 intolerance to ISIS 2922.

Prior Medication:

Excluded:

• Prior ganciclovir implant for CMV retinitis.

• More than 4 months of prior ganciclovir.

Study Design

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

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Fomivirsen sodium

• Ganciclovir

Locations

Country	Name	City	State
United States	Georgia Retina	Atlanta	Georgia
United States	Charlotte Eye Ear Nose and Throat Association	Charlotte	North Carolina
United States	Univ of Illinois	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
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	Vitreo - Retinal Consultants	New York	New York
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Community Eye Med Group	Pasadena	California
United States	Graduate Hosp	Philadelphia	Pennsylvania
United States	Hahnemann Univ Hosp	Philadelphia	Pennsylvania
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	Novum Inc	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,