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| Sponsored by: |
Hoffmann-La Roche |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002257 |
Purpose
To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.
| 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, Placebo Control, Safety Study |
| Official Title: | A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS |
| Estimated Enrollment: | 150 |
Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have the following:
Exclusion Criteria
Concurrent Medication:
The following are excluded:
Patients with the following are excluded:
Prior Medication:
The following are excluded:
- Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.
Contacts and Locations| United States, California | |||||
| Davies Med Ctr / c/o HIV Institute | |||||
| San Francisco, California, United States, 94114 | |||||
| East Bay AIDS Ctr | |||||
| Berkeley, California, United States, 94704 | |||||
| Dr David Busch | |||||
| San Francisco, California, United States, 94118 | |||||
| United States, District of Columbia | |||||
| Georgetown Univ Med Ctr | |||||
| Washington, District of Columbia, United States, 20007 | |||||
| United States, Florida | |||||
| Miami Veterans Administration Med Ctr | |||||
| Miami, Florida, United States, 33125 | |||||
| Med Service | |||||
| Miami, Florida, United States, 33125 | |||||
| United States, Illinois | |||||
| Rush Presbyterian - Saint Luke's Med Ctr | |||||
| Chicago, Illinois, United States, 60612 | |||||
| United States, Massachusetts | |||||
| Beth Israel Deaconess Med Ctr | |||||
| Boston, Massachusetts, United States, 02215 | |||||
| United States, New York | |||||
| New York Univ Med Ctr | |||||
| New York, New York, United States, 10016 | |||||
| Cornell Univ Med College | |||||
| New York, New York, United States, 10021 | |||||
| United States, Pennsylvania | |||||
| Buckley Braffman Stern Med Associates | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| United States, Texas | |||||
| Univ TX Galveston Med Branch | |||||
| Galveston, Texas, United States, 77550 | |||||
| Canada, British Columbia | |||||
| Saint Paul's Hosp | |||||
| Vancouver, British Columbia, Canada | |||||
| Hoffmann-La Roche |
More Information
| Study ID Numbers: | 059B, ICM 1653 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002257 |
| Health Authority: | United States: Food and Drug Administration |
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