Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: March 1996
History of Changes
PRIMARY: To compare the frequency of and time to relapse of Cytomegalovirus (CMV)
gastrointestinal disease following foscarnet induction therapy only versus induction plus
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.
Drug : Foscarnet sodium
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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- CMV GI disease.
- 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.
Patients with the following symptoms or conditions are excluded:
Contacts and LocationsChoosing 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 ClinicalTrials.gov identifier: NCT00002145
Locations Show More
|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|
Sponsors and CollaboratorsAstra USA
|Responsible Party:||Astra USA|
|ClinicalTrials.gov Identifier:||NCT00002145 History of Changes|
|Other Study ID Numbers:||020I|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Foscarnet
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Digestive System Diseases
ClinicalTrials.gov processed this data on July 10, 2020
This information is provided by ClinicalTrials.gov.