A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00002257
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.
- Detailed Description
Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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)
Saint Paul's Hosp
🇨🇦Vancouver, British Columbia, Canada
New York Univ Med Ctr
🇺🇸New York, New York, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Dr David Busch
🇺🇸San Francisco, California, United States
Buckley Braffman Stern Med Associates
🇺🇸Philadelphia, Pennsylvania, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Med Service
🇺🇸Miami, Florida, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Miami Veterans Administration Med Ctr
🇺🇸Miami, Florida, United States
Davies Med Ctr / c/o HIV Institute
🇺🇸San Francisco, California, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States