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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria Patients must have:


- 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

Page last updated: August 20, 2015

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