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

This study has been completed.

Sponsored by: Astra USA
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002125
  Purpose

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 Intervention Phase
Cytomegalovirus Retinitis
HIV Infections
Drug: Foscarnet sodium
Phase IV

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

Drug Information available for:   Foscarnet    Foscarnet sodium    Fosfonet sodium    Phosphonoacetic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   112

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002125

Locations
United States, California
AIDS Community Research Consortium    
      Redwood City, California, United States, 94063
Dr G Michael Wool    
      Los Angeles, California, United States, 90067
Dr Milan Fiala    
      Los Angeles, California, United States, 900246970
Dr Ralph Hansen    
      Beverly Hills, California, United States, 90210
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
Community Health Network    
      Rochester, New York, United States, 14620
Dr Ronald J Grossman    
      New York, New York, United States, 10016
United States, Texas
Austin Infectious Disease Consultants    
      Austin, Texas, United States, 78705

Sponsors and Collaborators
Astra USA

Investigators
Study Chair:     Wool GM    
  More Information


Study ID Numbers:   020H, 93-FOS-31
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002125
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis  
Infusions, Intravenous  
Foscarnet  
Cytomegalovirus Infections  
Administration, Oral
Acquired Immunodeficiency Syndrome
Fluid Therapy

Study placed in the following topic categories:
Phosphonoacetic Acid
Sexually Transmitted Diseases, Viral
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Cytomegalovirus retinitis
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Foscarnet
Cytomegalic inclusion disease
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Eye Infections, Viral
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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