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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Foscarnet sodium
Sponsored by
Astra USA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Infusions, Intravenous, Foscarnet, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome, Fluid Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr Ralph Hansen
  • Dr Milan Fiala
  • Dr G Michael Wool
  • AIDS Community Research Consortium
  • Ingenix Kern McNeill Decatur
  • Dr John Karedes
  • Dr Paul Benson
  • Dr Ronald Nahass
  • Dr Ronald J Grossman
  • Community Health Network
  • Austin Infectious Disease Consultants

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Astra USA
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1. Study Identification

Unique Protocol Identification Number
NCT00002125
Brief Title
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Official Title
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Study Type
Interventional

2. Study Status

Record Verification Date
June 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Astra USA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, Infusions, Intravenous, Foscarnet, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome, Fluid Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
112 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Foscarnet sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wool GM
Official's Role
Study Chair
Facility Information:
Facility Name
Dr Ralph Hansen
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Dr Milan Fiala
City
Los Angeles
State/Province
California
ZIP/Postal Code
900246970
Country
United States
Facility Name
Dr G Michael Wool
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Ingenix Kern McNeill Decatur
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Dr John Karedes
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46204
Country
United States
Facility Name
Dr Paul Benson
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Dr Ronald Nahass
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Dr Ronald J Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Austin Infectious Disease Consultants
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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