Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
NCT ID: NCT00002145
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
145 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Foscarnet sodium
Eligibility Criteria
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Inclusion Criteria
* AIDS.
* CMV GI disease.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Astra USA
INDUSTRY
Locations
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East Bay AIDS Ctr
Berkeley, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCSD
San Diego, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Emory Univ School of Medicine
Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Dr Robert Bresalier / Henry Ford Hosp
Detroit, Michigan, United States
Dr Douglas Dieterich
New York, New York, United States
Dept of Veterans Affairs
Northport, New York, United States
Ohio State Univ Hosp
Columbus, Ohio, United States
Comprehensive Care Ctr
Dallas, Texas, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Med College of Virginia
Richmond, Virginia, United States
Countries
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References
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Dieterich DT, Poles MA, Lew EA, Martin-Munley S, Johnson J, Nix D, Faust MJ. Treatment of gastrointestinal cytomegalovirus infection with twice-daily foscarnet: a pilot study of safety, efficacy, and pharmacokinetics in patients with AIDS. Antimicrob Agents Chemother. 1997 Jun;41(6):1226-30. doi: 10.1128/AAC.41.6.1226.
Other Identifiers
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93-FOS-29
Identifier Type: -
Identifier Source: secondary_id
020I
Identifier Type: -
Identifier Source: org_study_id