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

June 23, 2005 updated by: Astra USA

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment

145

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astra USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020I
  • 93-FOS-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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