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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fomivirsen sodium
Ganciclovir
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring AIDS-Related Opportunistic Infections, Ganciclovir, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis, Injections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina - Vitreous Associates Med Group
  • Community Eye Med Group
  • San Diego Naval Hosp
  • Univ of California San Francisco / SF Gen Hosp
  • Santa Clara Valley Med Ctr
  • Univ of Colorado Health Sciences Ctr
  • Dr Julio Perez
  • Georgia Retina
  • Univ of Illinois
  • Indiana Univ Med Ctr
  • Vitreo - Retinal Consultants
  • Charlotte Eye Ear Nose and Throat Association
  • Hahnemann Univ Hosp
  • Graduate Hosp
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Baylor College of Medicine
  • Virginia Eye Consultants
  • Novum Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00002156
Brief Title
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
Official Title
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
Study Type
Interventional

2. Study Status

Record Verification Date
December 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Ganciclovir, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis, Injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
194 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fomivirsen sodium
Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Retina - Vitreous Associates Med Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Community Eye Med Group
City
Pasadena
State/Province
California
ZIP/Postal Code
911052536
Country
United States
Facility Name
San Diego Naval Hosp
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Univ of California San Francisco / SF Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Dr Julio Perez
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Georgia Retina
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Univ of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Med Ctr
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Vitreo - Retinal Consultants
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Association
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Hahnemann Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Graduate Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191461192
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
752359057
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Novum Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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