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| Descriptive Information Fields | |
| Brief Title † | A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS |
| Official Title † | An Open Label Study of the Safety and Tolerability of Valganciclovir, an Oral Prodrug of Ganciclovir, for the Treatment of Cytomegalovirus Retinitis in Subjects With AIDS |
| Brief Summary | The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis in patients who have been treated for this condition in the past. This study also examines the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis. |
| Detailed Description | Patients receive valganciclovir twice a day for 21 days as induction therapy then daily as maintenance therapy. Patients are encouraged to remain on study for at least 3 months and will remain until common study closure. |
| Study Phase | |
| Study Type † | Interventional |
| Study Design † | Treatment, Open Label, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Cytomegalovirus Retinitis HIV Infections |
| Intervention † | Drug: Valganciclovir |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 200 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Concurrent Medication: Allowed with caution:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms of conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded:
Required:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002222 |
| Organization ID | 268B |
| Secondary IDs †† | |
| Study Sponsor † | Hoffmann-La Roche |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | April 1999 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |