Trials / Completed
CompletedNCT00002134
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (planned)
- Sponsor
- Roche Global Development · Academic / Other
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ganciclovir |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002134. Inclusion in this directory is not an endorsement.