A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 150
- Locations
- 23
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided