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

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: NCT00002145
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
HIV Infections Gastrointestinal Diseases Drug: Foscarnet sodium Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 145 participants
Primary Purpose: Treatment
Official Title: Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00002145


Locations
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United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
UCSD
San Diego, California, United States, 92103
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
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77555
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
United States, Virginia
Med College of Virginia
Richmond, Virginia, United States, 232980711
Sponsors and Collaborators
Astra USA
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00002145    
Other Study ID Numbers: 020I
93-FOS-29
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1996
Keywords provided by NIH AIDS Clinical Trials Information Service:
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Foscarnet
Phosphonoacetic Acid
Antiviral Agents
 Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action