Clinical Trials


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

This study has been completed
Astra USA

Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service Identifier

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: June 1997
History of Changes


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)

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

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.



Ages Eligible for Study: 18 Years and older  
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.

contacts and locations

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 identifier: NCT00002125


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


Study Chair: Wool GM
More Information

More Information

Responsible Party: Astra USA Identifier: NCT00002125   History of Changes  
Other Study ID Numbers: 020H  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Infusions, Intravenous
Cytomegalovirus Infections
Administration, Oral
Acquired Immunodeficiency Syndrome
Fluid Therapy

Additional relevant MeSH terms:
HIV Infections
Cytomegalovirus Retinitis
Phosphonoacetic Acid processed this data on August 14, 2018
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