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| Sponsor: | 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 |
| 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
More Information
| Study ID Numbers: | 059F, GANs2226 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002330 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Retinitis Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Retinitis Infection Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections Retinal Diseases RNA Virus Infections Immune System Diseases Eye Infections, Viral Eye Diseases |
Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Ganciclovir Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |