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Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

NCT00002145•Astra USA

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (15)

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

Key Dates

Last Updated

June 24, 2005

Enrollment

145

Estimated participants

Conditions

HIV InfectionsGastrointestinal Diseases

Interventions

Foscarnet sodium

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

Inclusion Criteria

Exclusion Criteria

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

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