A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections
Intervention: Foscarnet sodium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Astra USA Official(s) and/or principal investigator(s):
Wool GM, Study Chair
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.
Clinical Details
Official title: A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Study design: Primary Purpose: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Dr Ralph Hansen, Beverly Hills, California 90210, United States
Dr G Michael Wool, Los Angeles, California 90067, United States
Dr Milan Fiala, Los Angeles, California 900246970, 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
Additional Information
Last updated: June 23, 2005
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