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Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

This study has been completed.

Sponsored by: Astra USA
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002145
  Purpose

PRIMARY: To compare the frequency of and time to relapse of Cytomegalovirus (CMV) gastrointestinal disease following foscarnet induction therapy only versus induction plus maintenance therapy.

SECONDARY: To determine frequency of and time to recurrence of gastrointestinal symptoms, response rate of pathological lesions, and incidence of nongastrointestinal CMV disease in this patient population.


Condition Intervention Phase
HIV Infections
Gastrointestinal Diseases
Drug: Foscarnet sodium
Phase III

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, Efficacy Study
Official Title:   Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

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

Estimated Enrollment:   145

Detailed Description:

Patients receive intravenous foscarnet either as induction only for 4 weeks or as induction for 4 weeks followed by maintenance for 22 weeks. All patients are followed for 26 weeks or until relapse.

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

Criteria

Inclusion Criteria

Patients must have:

  • AIDS.
  • CMV GI disease.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Non-GI CMV disease.
  • Ulcerative colitis, inflammatory bowel disease, or other condition that may interfere with study results.
  • Other GI pathogens.

Concurrent Medication:

Excluded:

  • Drugs that may interact with foscarnet.
  • Systemic acyclovir, ganciclovir, or acyclovir prodrug.
  • Drugs known to affect renal function.

Prior Medication:

Excluded:

  • Prior foscarnet in extremis.
  • Investigational agents other than 3TC or d4T within 7 days prior to study entry.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002145

Locations
United States, California
East Bay AIDS Ctr    
      Berkeley, California, United States, 94705
UCSD    
      San Diego, California, United States, 92103
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
UCSF - San Francisco Gen Hosp    
      San Francisco, California, United States, 94110
United States, Florida
Miami Veterans Administration Med Ctr    
      Miami, Florida, United States, 33125
United States, Georgia
Emory Univ School of Medicine    
      Atlanta, Georgia, United States, 30303
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr    
      Chicago, Illinois, United States, 60612
United States, Michigan
Dr Robert Bresalier / Henry Ford Hosp    
      Detroit, Michigan, United States, 48202
United States, New York
Dr Douglas Dieterich    
      New York, New York, United States, 10016
Dept of Veterans Affairs    
      Northport, New York, United States, 11768
United States, Ohio
Ohio State Univ Hosp    
      Columbus, Ohio, United States, 43210
United States, Texas
Comprehensive Care Ctr    
      Dallas, Texas, United States, 75235
Houston Veterans Administration Med Ctr    
      Houston, Texas, United States, 77030
Univ TX Galveston Med Branch    
      Galveston, Texas, United States, 77555
United States, Virginia
Med College of Virginia    
      Richmond, Virginia, United States, 232980711

Sponsors and Collaborators
Astra USA
  More Information


Publications:

Study ID Numbers:   020I, 93-FOS-29
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002145
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Foscarnet  
Cytomegalovirus Infections  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Phosphonoacetic Acid
Sexually Transmitted Diseases, Viral
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Cytomegalovirus
Immunologic Deficiency Syndromes
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
Foscarnet
Retroviridae Infections
Cytomegalic inclusion disease

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
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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