A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
2 other identifiers
interventional
112
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1997
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astra USAlead
Study Sites (11)
Dr Ralph Hansen
Beverly Hills, California, 90210, United States
Dr Milan Fiala
Los Angeles, California, 900246970, United States
Dr G Michael Wool
Los Angeles, California, 90067, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
Ingenix Kern McNeill Decatur
Atlanta, Georgia, 30309, United States
Dr John Karedes
Indianapolis, Indiana, 46204, United States
Dr Paul Benson
Berkley, Michigan, 48072, United States
Dr Ronald Nahass
Somerville, New Jersey, 08876, United States
Dr Ronald J Grossman
New York, New York, 10016, United States
Community Health Network
Rochester, New York, 14620, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wool GM
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1997-06