A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00002247
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To describe the efficacy and safety of double dose versus single dose oral ganciclovir in patients who have a progression of retinitis while on the originally assigned maintenance treatment. To describe the safety, tolerance, and time to progression of retinitis during the 52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety and tolerance of oral ganciclovir maintenance therapy when given concurrently with antiretroviral treatment (e.g., zidovudine, ddI, or ddC). To describe survival of people with AIDS and CMV retinitis.
- Detailed Description
Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A, B, and C of the study, provided that each subject has received and tolerated a therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in stable retinitis. An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research and have stable retinitis may enter into Group D of this study and receive oral ganciclovir.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
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 (20)
Mount Zion Med Ctr
🇺🇸San Francisco, California, United States
Dr Dorothy Friedberg
🇺🇸New York, New York, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
AIDS Clinical Research Ctr / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Saint Paul's Hosp
🇨🇦Vancouver, British Columbia, Canada
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
🇺🇸Chicago, Illinois, United States
Buckley Braffman Stern Med Associates
🇺🇸Philadelphia, Pennsylvania, United States
Miami Veterans Administration Med Ctr
🇺🇸Miami, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Margo Heath - Chiozzi
🇺🇸Honolulu, Hawaii, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Oak Lawn Physicians Group
🇺🇸Dallas, Texas, United States
Beth Israel Hosp
🇺🇸Boston, Massachusetts, United States
Univ of Washington / Pacific Med Ctr
🇺🇸Seattle, Washington, United States
UCSD Med Ctr / Pediatrics
🇺🇸San Diego, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Davies Med Ctr / c/o HIV Institute
🇺🇸San Francisco, California, United States
Dr David Busch
🇺🇸San Francisco, California, United States
Cornell Univ Med College
🇺🇸New York, New York, United States