A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
NCT ID: NCT00002125
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
112 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Foscarnet sodium
Eligibility Criteria
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Inclusion Criteria
* Documented HIV infection.
* Recent diagnosis of CMV retinitis, by ophthalmoscopic appearance, that requires induction therapy.
* No corneal, lens, or vitreous opacification that precludes examination of the fundi.
* No evidence of other end organ CMV infection.
* No evidence of tuberculous, diabetic, or hypertensive retinopathy.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Clinically significant cardiac, pulmonary, neurologic, gastrointestinal or renal impairment that would prevent adequate voluntary oral hydration (e.g., intubation, coma, status post-gastrectomy, colon resection, gastrointestinal tumors, malabsorption, chronic diarrhea) OR with which hydration would be hazardous (e.g., congestive heart failure).
* Known allergy to foscarnet or related compounds.
* Considered noncompliant or unreliable for study participation.
Concurrent Medication:
Excluded:
* Any investigational drug.
* Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin).
Prior Medication:
Excluded:
* Any investigational drug within 28 days prior to study entry.
* Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin) within 7 days prior to study entry.
18 Years
ALL
No
Sponsors
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Astra USA
INDUSTRY
Principal Investigators
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Wool GM
Role: STUDY_CHAIR
Locations
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Dr Ralph Hansen
Beverly Hills, California, United States
Dr Milan Fiala
Los Angeles, California, United States
Dr G Michael Wool
Los Angeles, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
Ingenix Kern McNeill Decatur
Atlanta, Georgia, United States
Dr John Karedes
Indianapolis, Indiana, United States
Dr Paul Benson
Berkley, Michigan, United States
Dr Ronald Nahass
Somerville, New Jersey, United States
Dr Ronald J Grossman
New York, New York, United States
Community Health Network
Rochester, New York, United States
Austin Infectious Disease Consultants
Austin, Texas, United States
Countries
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Other Identifiers
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93-FOS-31
Identifier Type: -
Identifier Source: secondary_id
020H
Identifier Type: -
Identifier Source: org_study_id