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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fomivirsen sodium
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 Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis

Eligibility Criteria

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

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.

Sites / Locations

  • UCI College of Medicine
  • 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 Alan Palestine
  • Dr Julio Perez
  • Bascon Palmer Eye Institute
  • Emory Univ School of Medicine / Emory Eye Ctr
  • Georgia Retina
  • Univ of Illinois
  • Indiana Univ Med Ctr
  • Tulane Univ
  • Vitreo - Retinal Consultants
  • Charlotte Eye Ear Nose & Throat Association
  • Duke Univ
  • Hahnemann Univ Hosp
  • Graduate Hosp
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Vitreoretinal Consultants
  • 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
NCT00002356
Brief Title
The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fomivirsen sodium

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 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.
Facility Information:
Facility Name
UCI College of Medicine
City
Irvine
State/Province
California
ZIP/Postal Code
92715
Country
United States
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 Alan Palestine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Dr Julio Perez
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Bascon Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory Univ School of Medicine / Emory Eye Ctr
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
Tulane Univ
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
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 & Throat Association
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Univ
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
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
Vitreoretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
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

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

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