Clinical trial NCT00002159: A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
Official title: A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Histoplasmosis
Blastomycosis
Keywords: Itraconazole
Histoplasmosis
Antifungal Agents
Acquired Immunodeficiency Syndrome
Amphotericin B
AIDS-Related Complex
Blastomycosis
Antibiotics, Antifungal
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.

Detailed description: Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV positive or negative status.
* Blastomycosis or histoplasmosis.
* Life expectancy of at least 1 week.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Liver disease.
* Self-limiting fungal disease.
* Very severe fungal disease such as meningeal involvement.
* Acute respiratory disease.

Concurrent Medication:

Excluded at any time:

* Terfenadine.
* Astemizole.
* Oral midazolam.
* Triazolam.
* Cisapride.
* Phenytoin.
* Phenobarbital.
* Rifampin.
* Rifabutin.

Excluded during oral consolidation:

* H2 blockers.
* Chronic antacids.
* Omeprazole.
* Lansoprazole.

Patients with the following prior condition are excluded:

Hypersensitivity to azole antifungals.

Prior Medication:

Excluded at any time:

More than 3 days of amphotericin B, fluconazole, or ketoconazole.

Excluded within 2 weeks prior to study entry:

* Phenytoin.
* Phenobarbital.
* Rifampin.
* Rifabutin.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Station / Infectious Division
state: Alabama
city: Little Rock
country: United States
facility: Univ of Arkansas for Med Sciences
state: Arkansas
city: Atlanta
country: United States
facility: Division of Infectious Diseases
state: Georgia
city: Indianapolis
country: United States
facility: Division of Inf Diseases/ Indiana Univ Hosp
state: Indiana
city: Indianapolis
country: United States
facility: Community Hosp
state: Indiana
city: Shreveport
country: United States
facility: LSU Med Ctr / Div of Pulmonary & Critical Care Med
state: Louisiana
city: Ann Arbor
country: United States
facility: Ann Arbor Veterans Administration Med Ctr
state: Michigan
city: Kansas City
country: United States
facility: Univ of Missouri / Division of Infectious Diseases
state: Missouri
city: Kansas City
country: United States
facility: Infectious Diseases Association / Research Med Ctr
state: Missouri
Study officials:
References: