Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Gastrointestinal Diseases
Intervention: Foscarnet sodium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astra USA
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.
Clinical Details
Official title: Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Study design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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
Additional Information
Related publications: 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.
Last updated: June 23, 2005
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