A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00002156
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 194
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 (18)
Retina - Vitreous Associates Med Group
🇺🇸Los Angeles, California, United States
Community Eye Med Group
🇺🇸Pasadena, California, 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
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Dr Julio Perez
🇺🇸Fort Lauderdale, Florida, United States
Georgia Retina
🇺🇸Atlanta, Georgia, United States
Univ of Illinois
🇺🇸Chicago, Illinois, United States
Indiana Univ Med Ctr
🇺🇸Indianapolis, Indiana, United States
Scroll for more (8 remaining)Retina - Vitreous Associates Med Group🇺🇸Los Angeles, California, United States