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A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)

Phase 4
Completed
Conditions
Cytomegalovirus Retinitis
HIV Infections
Registration Number
NCT00002125
Lead Sponsor
Astra USA
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
112
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Dr Ronald Nahass

🇺🇸

Somerville, New Jersey, United States

Dr Milan Fiala

🇺🇸

Los Angeles, California, United States

Dr Ralph Hansen

🇺🇸

Beverly Hills, California, United States

Dr G Michael Wool

🇺🇸

Los Angeles, California, United States

Ingenix Kern McNeill Decatur

🇺🇸

Atlanta, Georgia, United States

AIDS Community Research Consortium

🇺🇸

Redwood City, California, United States

Dr John Karedes

🇺🇸

Indianapolis, Indiana, United States

Dr Paul Benson

🇺🇸

Berkley, Michigan, United States

Dr Ronald J Grossman

🇺🇸

New York, New York, United States

Austin Infectious Disease Consultants

🇺🇸

Austin, Texas, United States

Community Health Network

🇺🇸

Rochester, New York, United States

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