Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Completed · Phase 3
Conditions studied: HIV Infections, Gastrointestinal Diseases
In brief
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.
Key facts
- Study ID
- NCT00002145
- Run by
- Astra USA
- People needed
- 145
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- AIDS.
- CMV GI disease.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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