A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00002355
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Brief Summary
To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.
- Detailed Description
In Stage 1 (dose escalation), patients receive either 75 or 150 mcg intravitreal ISIS 2922. In Stage 2 (randomization), patients are enrolled in either the immediate treatment group or delayed treatment group. Immediate treatment consists of intravitreal ISIS 2922 every 7 days for 3 injections (Induction) then every 14 days for 18 weeks (Maintenance). Patients in the delayed treatment group receive no immediate anti-CMV treatment but are monitored weekly for disease progression. If disease progresses, patient receives ISIS 2922 on an identical dosage regimen as those on immediate treatment. Patients may continue ISIS 2922 on a biweekly extended maintenance schedule if dose is considered safe and the CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 (13)
Dr Julio Perez
🇺🇸Fort Lauderdale, Florida, United States
Univ of Texas Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Univ of Illinois
🇺🇸Chicago, Illinois, United States
Vitreo - Retinal Consultants
🇺🇸New York, New York, United States
Georgia Retina
🇺🇸Atlanta, Georgia, United States
Novum Inc
🇺🇸Seattle, Washington, United States
Santa Clara Valley Med Ctr
🇺🇸San Jose, California, United States
Retina - Vitreous Associates Med Group
🇺🇸Los Angeles, California, United States
Charlotte Eye Ear Nose & Throat Association
🇺🇸Charlotte, North Carolina, United States
Community Eye Med Group
🇺🇸Pasadena, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Indiana Univ Med Ctr
🇺🇸Indianapolis, Indiana, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States