Phase III Multicenter, Open-Label, Randomized Trial of NCT00002145

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00002145
Other study ID #	020I
Secondary ID	93-FOS-29
Status	Completed
Phase	Phase 3
First received	November 2, 1999
Last updated	June 23, 2005

Study information
Verified date	March 1996
Source	NIH AIDS Clinical Trials Information Service
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	145
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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 Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Foscarnet sodium

Locations
Country	Name	City	State
United States	Emory Univ School of Medicine	Atlanta	Georgia
United States	East Bay AIDS Ctr	Berkeley	California
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Ohio State Univ Hosp	Columbus	Ohio
United States	Comprehensive Care Ctr	Dallas	Texas
United States	Dr Robert Bresalier / Henry Ford Hosp	Detroit	Michigan
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Houston Veterans Administration Med Ctr	Houston	Texas
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Dr Douglas Dieterich	New York	New York
United States	Dept of Veterans Affairs	Northport	New York
United States	Med College of Virginia	Richmond	Virginia
United States	UCSD	San Diego	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California

Sponsors *(1)*
Lead Sponsor	Collaborator
Astra USA

Country where clinical trial is conducted

United States,

References & Publications (1)

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. — View Citation

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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 Trial Details — Status: Completed

Administrative data

Study information