- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002125
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
June 23, 2005 updated by: Astra USA
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment
112
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Beverly Hills, California, United States, 90210
- Dr Ralph Hansen
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Los Angeles, California, United States, 900246970
- Dr Milan Fiala
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Los Angeles, California, United States, 90067
- Dr G Michael Wool
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Redwood City, California, United States, 94063
- AIDS Community Research Consortium
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Georgia
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Atlanta, Georgia, United States, 30309
- Ingenix Kern McNeill Decatur
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Indiana
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Indianapolis, Indiana, United States, 46204
- Dr John Karedes
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Michigan
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Berkley, Michigan, United States, 48072
- Dr Paul Benson
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New Jersey
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Somerville, New Jersey, United States, 08876
- Dr Ronald Nahass
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New York
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New York, New York, United States, 10016
- Dr Ronald J Grossman
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Rochester, New York, United States, 14620
- Community Health Network
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Texas
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Austin, Texas, United States, 78705
- Austin Infectious Disease Consultants
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Patients must have:
- 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
Co-existing Condition:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Wool GM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
June 1, 1997
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Eye Diseases
- Retinal Diseases
- DNA Virus Infections
- Herpesviridae Infections
- Eye Infections
- Eye Infections, Viral
- Cytomegalovirus Infections
- Retinitis
- Cytomegalovirus Retinitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Foscarnet
- Phosphonoacetic Acid
Other Study ID Numbers
- 020H
- 93-FOS-31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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