Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
- Conditions
- HIV InfectionsGastrointestinal Diseases
- Registration Number
- NCT00002145
- Lead Sponsor
- Astra USA
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
UCSD
🇺🇸San Diego, California, United States
Dr Douglas Dieterich
🇺🇸New York, New York, United States
Dept of Veterans Affairs
🇺🇸Northport, New York, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Miami Veterans Administration Med Ctr
🇺🇸Miami, Florida, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Emory Univ School of Medicine
🇺🇸Atlanta, Georgia, 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
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Dr Robert Bresalier / Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Med College of Virginia
🇺🇸Richmond, Virginia, United States