NCT00002159

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 hiv-infections

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsHistoplasmosisBlastomycosis

Keywords

ItraconazoleHistoplasmosisAntifungal AgentsAcquired Immunodeficiency SyndromeAmphotericin BAIDS-Related ComplexBlastomycosisAntibiotics, Antifungal

Interventions

ItraconazoleDRUG
Amphotericin BDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • HIV positive or negative status.
  • Blastomycosis or histoplasmosis.
  • Life expectancy of at least 1 week.

You may not qualify if:

  • 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.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UAB Station / Infectious Division

Birmingham, Alabama, 35294, United States

Location

Univ of Arkansas for Med Sciences

Little Rock, Arkansas, 72205, United States

Location

Division of Infectious Diseases

Atlanta, Georgia, 30303, United States

Location

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, 46202, United States

Location

Community Hosp

Indianapolis, Indiana, 46218, United States

Location

LSU Med Ctr / Div of Pulmonary & Critical Care Med

Shreveport, Louisiana, 71130, United States

Location

Ann Arbor Veterans Administration Med Ctr

Ann Arbor, Michigan, 48105, United States

Location

Univ of Missouri / Division of Infectious Diseases

Kansas City, Missouri, 641082792, United States

Location

Infectious Diseases Association / Research Med Ctr

Kansas City, Missouri, 64132, United States

Location

MeSH Terms

Conditions

HIV InfectionsHistoplasmosisBlastomycosisAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

ItraconazoleAmphotericin B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycosesBacterial Infections and MycosesDermatomycosesLung Diseases, FungalRespiratory Tract InfectionsSkin Diseases, InfectiousLung DiseasesRespiratory Tract DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-12

Locations

US(9)