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| Sponsored by: |
Roche Global Development |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002330 |
Purpose
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.
| Condition | Intervention |
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
| MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
| Drug Information available for: | Ganciclovir Ganciclovir sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | 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 |
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations![]() |
Show 36 Study Locations |
| Roche Global Development |
More Information
|
Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)
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| Study ID Numbers: | 059F, GANs2226 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002330 |
| Health Authority: | United States: Food and Drug Administration |
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