Clinical trial NCT00002145: Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Official title: Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Gastrointestinal Diseases
Keywords: Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Atlanta
country: United States
facility: Emory Univ School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Detroit
country: United States
facility: Dr Robert Bresalier / Henry Ford Hosp
state: Michigan
city: New York
country: United States
facility: Dr Douglas Dieterich
state: New York
city: Northport
country: United States
facility: Dept of Veterans Affairs
state: New York
city: Columbus
country: United States
facility: Ohio State Univ Hosp
state: Ohio
city: Dallas
country: United States
facility: Comprehensive Care Ctr
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Houston
country: United States
facility: Houston Veterans Administration Med Ctr
state: Texas
city: Richmond
country: United States
facility: Med College of Virginia
state: Virginia
Study officials:
References:
citation: 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. doi: 10.1128/AAC.41.6.1226.