A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
NCT00002134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2005-06-24
Summary
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
Conditions
- Cytomegalovirus Retinitis
- HIV Infections
Interventions
- DRUG
-
Ganciclovir
Sponsors & Collaborators
-
Roche Global Development
lead OTHER
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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