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

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.

Sponsored by:	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

MedlinePlus related topics:

AIDS Cytomegalovirus Infections

Drug Information available for:

Foscarnet Foscarnet sodium Fosfonet sodium Phosphonoacetic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study

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

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
	UCSD
	San Diego, California, United States, 92103
	Los Angeles County - USC Med Ctr
	Los Angeles, California, United States, 90033
	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
	Houston Veterans Administration Med Ctr
	Houston, Texas, United States, 77030
	Univ TX Galveston Med Branch
	Galveston, Texas, United States, 77555

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.

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

Keywords provided by NIH AIDS Clinical Trials Information Service:

Foscarnet

Cytomegalovirus Infections

Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:

Phosphonoacetic Acid

Sexually Transmitted Diseases, Viral

Gastrointestinal Diseases

Acquired Immunodeficiency Syndrome

Cytomegalovirus

Immunologic Deficiency Syndromes

Virus Diseases

Digestive System Diseases

HIV Infections

Sexually Transmitted Diseases

Cytomegalovirus Infections

Foscarnet

Retroviridae Infections

Cytomegalic inclusion disease

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008