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

Last updated: June 23, 2005
Sponsor: Astra USA
Overall Status: Completed

Phase

4

Condition

Eye Disorders/infections

Hiv Infections

Cytomegalovirus Infections

Treatment

N/A

Clinical Study ID

NCT00002125
020H
93-FOS-31
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 112
Study Start date:
Estimated Completion Date:

Study 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.

Connect with a study center

  • Dr Ralph Hansen

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Dr G Michael Wool

    Los Angeles, California 90067
    United States

    Site Not Available

  • Dr Milan Fiala

    Los Angeles, California 900246970
    United States

    Site Not Available

  • AIDS Community Research Consortium

    Redwood City, California 94063
    United States

    Site Not Available

  • Ingenix Kern McNeill Decatur

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Dr John Karedes

    Indianapolis, Indiana 46204
    United States

    Site Not Available

  • Dr Paul Benson

    Berkley, Michigan 48072
    United States

    Site Not Available

  • Dr Ronald Nahass

    Somerville, New Jersey 08876
    United States

    Site Not Available

  • Dr Ronald J Grossman

    New York, New York 10016
    United States

    Site Not Available

  • Community Health Network

    Rochester, New York 14620
    United States

    Site Not Available

  • Austin Infectious Disease Consultants

    Austin, Texas 78705
    United States

    Site Not Available

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