Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
2 other identifiers
interventional
145
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astra USAlead
Study Sites (15)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCSD
San Diego, California, 92103, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Dr Robert Bresalier / Henry Ford Hosp
Detroit, Michigan, 48202, United States
Dr Douglas Dieterich
New York, New York, 10016, United States
Dept of Veterans Affairs
Northport, New York, 11768, United States
Ohio State Univ Hosp
Columbus, Ohio, 43210, United States
Comprehensive Care Ctr
Dallas, Texas, 75235, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77555, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, United States
Med College of Virginia
Richmond, Virginia, 232980711, United States
Related Publications (1)
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.
PMID: 9174175BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-03