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

J

Janssen (J&J Innovative Medicine)

Status and phase

Completed
Phase 3

Conditions

Blastomycosis
Histoplasmosis
HIV Infections

Treatments

Drug: Amphotericin B
Drug: Itraconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002159
ITR-USA-118
254A

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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