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| Sponsored by: |
Astra USA |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002125 |
Purpose
To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate the timing and volume of oral fluid hydration required to establish a diuresis before and during intravenous Foscavir therapy. To assess the general tolerance of two hydration regimens by the adverse event profile associated with each.
| Condition | Intervention | Phase |
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Foscarnet sodium |
Phase IV |
| MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
| Drug Information available for: | Foscarnet Foscarnet sodium Fosfonet sodium Phosphonoacetic acid |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium) |
| Estimated Enrollment: | 112 |
Patients are randomized to receive oral hydration versus intravenous hydration therapy during concomitant intermittent intravenous Foscavir therapy for treatment of cytomegalovirus (CMV) retinitis. Treatment continues during 2 or 3 weeks of induction Foscavir therapy.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Contacts and Locations| United States, California | |||||
| AIDS Community Research Consortium | |||||
| Redwood City, California, United States, 94063 | |||||
| Dr G Michael Wool | |||||
| Los Angeles, California, United States, 90067 | |||||
| Dr Milan Fiala | |||||
| Los Angeles, California, United States, 900246970 | |||||
| Dr Ralph Hansen | |||||
| Beverly Hills, California, United States, 90210 | |||||
| United States, Georgia | |||||
| Ingenix Kern McNeill Decatur | |||||
| Atlanta, Georgia, United States, 30309 | |||||
| United States, Indiana | |||||
| Dr John Karedes | |||||
| Indianapolis, Indiana, United States, 46204 | |||||
| United States, Michigan | |||||
| Dr Paul Benson | |||||
| Berkley, Michigan, United States, 48072 | |||||
| United States, New Jersey | |||||
| Dr Ronald Nahass | |||||
| Somerville, New Jersey, United States, 08876 | |||||
| United States, New York | |||||
| Community Health Network | |||||
| Rochester, New York, United States, 14620 | |||||
| Dr Ronald J Grossman | |||||
| New York, New York, United States, 10016 | |||||
| United States, Texas | |||||
| Austin Infectious Disease Consultants | |||||
| Austin, Texas, United States, 78705 | |||||
| Astra USA |
| Study Chair: | Wool GM |
More Information
| Study ID Numbers: | 020H, 93-FOS-31 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002125 |
| Health Authority: | United States: Food and Drug Administration |
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