The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00002356
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
UCI College of Medicine
🇺🇸Irvine, California, United States
Emory Univ School of Medicine / Emory Eye Ctr
🇺🇸Atlanta, Georgia, United States
Hahnemann Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Texas Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Charlotte Eye Ear Nose & Throat Association
🇺🇸Charlotte, North Carolina, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
Community Eye Med Group
🇺🇸Pasadena, California, United States
Retina - Vitreous Associates Med Group
🇺🇸Los Angeles, California, United States
Santa Clara Valley Med Ctr
🇺🇸San Jose, California, United States
Dr Julio Perez
🇺🇸Fort Lauderdale, Florida, United States
Georgia Retina
🇺🇸Atlanta, Georgia, United States
Univ of Illinois
🇺🇸Chicago, Illinois, United States
Dr Alan Palestine
🇺🇸Washington, District of Columbia, United States
Vitreo - Retinal Consultants
🇺🇸New York, New York, United States
Graduate Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Vitreoretinal Consultants
🇺🇸Houston, Texas, United States
Novum Inc
🇺🇸Seattle, Washington, United States
San Diego Naval Hosp
🇺🇸San Diego, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Duke Univ
🇺🇸Durham, North Carolina, United States
Bascon Palmer Eye Institute
🇺🇸Miami, Florida, United States
Indiana Univ Med Ctr
🇺🇸Indianapolis, Indiana, United States
Tulane Univ
🇺🇸New Orleans, Louisiana, United States
Univ of California San Francisco / SF Gen Hosp
🇺🇸San Francisco, California, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States