Back to resultsPhase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Primary Purpose
HIV Infections, Gastrointestinal Diseases
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Foscarnet sodium
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Patients must have: AIDS. CMV GI disease. Exclusion Criteria 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.
Sites / Locations
- East Bay AIDS Ctr
- Los Angeles County - USC Med Ctr
- UCSD
- UCSF - San Francisco Gen Hosp
- Miami Veterans Administration Med Ctr
- Emory Univ School of Medicine
- Rush Presbyterian - Saint Luke's Med Ctr
- Dr Robert Bresalier / Henry Ford Hosp
- Dr Douglas Dieterich
- Dept of Veterans Affairs
- Ohio State Univ Hosp
- Comprehensive Care Ctr
- Univ TX Galveston Med Branch
- Houston Veterans Administration Med Ctr
- Med College of Virginia
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002145
Brief Title
Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Official Title
Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Astra USA
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Gastrointestinal Diseases
Keywords
Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
145 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Foscarnet sodium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
AIDS.
CMV GI disease.
Exclusion Criteria
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.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Emory Univ School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Dr Robert Bresalier / Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dr Douglas Dieterich
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Dept of Veterans Affairs
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
Ohio State Univ Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Comprehensive Care Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Houston Veterans Administration Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Med College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
232980711
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9174175
Citation
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.
Results Reference
background
Learn more about this trial
Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
We'll reach out to this number within 24 hrs