We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002125
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Retinitis HIV Infections Drug: Foscarnet sodium Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 112 participants
Primary Purpose: Treatment
Official Title: A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • Any investigational drug.
  • Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin).

Prior Medication:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002125

Layout table for location information
United States, California
Dr Ralph Hansen
Beverly Hills, California, United States, 90210
Dr Milan Fiala
Los Angeles, California, United States, 900246970
Dr G Michael Wool
Los Angeles, California, United States, 90067
AIDS Community Research Consortium
Redwood City, California, United States, 94063
United States, Georgia
Ingenix Kern McNeill Decatur
Atlanta, Georgia, United States, 30309
United States, Indiana
Dr John Karedes
Indianapolis, Indiana, United States, 46204
United States, Michigan
Dr Paul Benson
Berkley, Michigan, United States, 48072
United States, New Jersey
Dr Ronald Nahass
Somerville, New Jersey, United States, 08876
United States, New York
Dr Ronald J Grossman
New York, New York, United States, 10016
Community Health Network
Rochester, New York, United States, 14620
United States, Texas
Austin Infectious Disease Consultants
Austin, Texas, United States, 78705
Sponsors and Collaborators
Astra USA
Layout table for investigator information
Study Chair: Wool GM
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00002125    
Other Study ID Numbers: 020H
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 1997
Keywords provided by NIH AIDS Clinical Trials Information Service:
Infusions, Intravenous
Cytomegalovirus Infections
Administration, Oral
Acquired Immunodeficiency Syndrome
Fluid Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Cytomegalovirus Retinitis
Virus Diseases
Retinal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Phosphonoacetic Acid
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action