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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002330 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS |
| Official Title ICMJE | A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS |
| Brief Summary | To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks. |
| Detailed Description | Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance. |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Ganciclovir |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 280 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir or ganciclovir. Prior Medication: Excluded:
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| Gender | Both |
| Ages | 13 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Canada |
| Administrative Information | |
| NCT ID ICMJE | NCT00002330 |
| Responsible Party | |
| Study ID Numbers ICMJE | 059F, GANs2226 |
| Study Sponsor ICMJE | Roche Global Development |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | April 1996 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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