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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002125
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1997
  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 4

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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Locations
United States, California
Dr Ralph Hansen
Beverly Hills, California, United States, 90210
Dr G Michael Wool
Los Angeles, California, United States, 90067
Dr Milan Fiala
Los Angeles, California, United States, 900246970
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
Investigators
Study Chair: Wool GM
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002125     History of Changes
Other Study ID Numbers: 020H, 93-FOS-31
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Phosphonoacetic Acid
Foscarnet
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014