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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Astra USA
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002145

Purpose

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.

Condition	Intervention	Phase
HIV Infections Gastrointestinal Diseases	Drug: Foscarnet sodium	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Primary Purpose: Treatment
Official Title:	Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Fosfonet sodium Foscarnet sodium Phosphonoacetic acid Foscarnet

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

145

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002145

Locations

United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
UCSD
San Diego, California, United States, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, Florida
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
United States, Georgia
Emory Univ School of Medicine
Atlanta, Georgia, United States, 30303
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Michigan
Dr Robert Bresalier / Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, New York
Dr Douglas Dieterich
New York, New York, United States, 10016
Dept of Veterans Affairs
Northport, New York, United States, 11768
United States, Ohio
Ohio State Univ Hosp
Columbus, Ohio, United States, 43210
United States, Texas
Comprehensive Care Ctr
Dallas, Texas, United States, 75235
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77555
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
United States, Virginia
Med College of Virginia
Richmond, Virginia, United States, 232980711

Sponsors and Collaborators

Astra USA

More Information

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.

ClinicalTrials.gov Identifier:	NCT00002145 History of Changes
Other Study ID Numbers:	020I, 93-FOS-29
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Gastrointestinal Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Digestive System Diseases
Foscarnet
Phosphonoacetic Acid
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on February 12, 2012