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

Sponsor

Astra USA (Industry)

Overall Status

Completed

CT.gov ID

NCT00002145

Collaborator

(none)

145

Enrollment

Locations

9.7

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Gastrointestinal Diseases	Drug: Foscarnet sodium	Phase 3

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 Design

Study Type:

Interventional

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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