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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
225
East Bay AIDS Ctr
Berkeley, California, United States
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, 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
Mount Zion Med Ctr
San Francisco, California, United States
Dr David Busch
San Francisco, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
...and 10 more locations
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