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NCT00002159 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002159
Other study ID # 254A
Secondary ID ITR-USA-118
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date December 1997
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

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Itraconazole

• Amphotericin B

Locations
Country Name City State
United States Ann Arbor Veterans Administration Med Ctr Ann Arbor Michigan
United States Division of Infectious Diseases Atlanta Georgia
United States UAB Station / Infectious Division Birmingham Alabama
United States Community Hosp Indianapolis Indiana
United States Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana
United States Infectious Diseases Association / Research Med Ctr Kansas City Missouri
United States Univ of Missouri / Division of Infectious Diseases Kansas City Missouri
United States Univ of Arkansas for Med Sciences Little Rock Arkansas
United States LSU Med Ctr / Div of Pulmonary & Critical Care Med Shreveport Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Janssen, LP

Country where clinical trial is conducted

United States, 

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