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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
150
East Bay AIDS Ctr
Berkeley, California, United States
Davies Med Ctr / c/o HIV Institute
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
Med Service
Miami, Florida, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
New York Univ Med Ctr
New York, New York, United States
Cornell Univ Med College
New York, New York, United States
...and 3 more locations
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