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
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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|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||145 participants|
|Official Title:||Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease|
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- CMV GI disease.
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.
- Drugs that may interact with foscarnet.
- Systemic acyclovir, ganciclovir, or acyclovir prodrug.
- Drugs known to affect renal function.
- Prior foscarnet in extremis.
- Investigational agents other than 3TC or d4T within 7 days prior to study entry.
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
|United States, California|
|East Bay AIDS Ctr|
|Berkeley, California, United States, 94705|
|Los Angeles County - USC Med Ctr|
|Los Angeles, California, United States, 90033|
|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|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||March 1996|
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Digestive System Diseases
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Molecular Mechanisms of Pharmacological Action