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Itraconazole

Phase 4FDA approved

HIV Infections | Small molecule | Infectious Disease |Johnson & Johnson|Trials Updated: Jun 24, 2005

Itraconazole development status

FDA approval on record Mar 30, 1999 as Sporanox
Approval holderJanssen Pharms
ApplicationNDA020966
Highest phase Phase 4 (NCT00871728)
Phase scored for JNJPhase 3
Registered trials 218 across 73 sponsors since Aug 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Itraconazole clinical trials

Itraconazole · 1 trial · 3 indications

Phase 3 1
NCT00002159A 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 HistoplasmosisHIV Infections
COMPLETED60 Analytics
PHASE3COMPLETED
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 InfectionsUnlock trial analytics

Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
ItraconazoleDRUG -
Amphotericin BDRUG -
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Eligibility Criteria

Age Range13 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 ...

Countries:United States
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Frequently asked questions about Itraconazole

What is itraconazole used for in HIV infections?

Itraconazole is an antifungal small molecule studied in Phase 3 for treating fungal infections in people with HIV. The completed trial evaluated it in patients with blastomycosis or histoplasmosis, two invasive fungal diseases that occur in immunocompromised individuals. It was given both intravenously and as oral capsules.

Who makes itraconazole?

Itraconazole is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 3 study of the drug in patients with HIV infections who also had blastomycosis or histoplasmosis.

What phase is itraconazole in?

Itraconazole is in Phase 3 development for HIV Infections, specifically for fungal infections such as blastomycosis and histoplasmosis in patients with HIV. The single Phase 3 trial has been completed, and no trials are currently active.

What clinical trials is itraconazole in?

Itraconazole was studied in one Phase 3 trial, NCT00002159, titled a randomized, open, comparative multicenter study of initial treatment with intravenous itraconazole versus amphotericin B followed by consolidation treatment with itraconazole capsules. The trial enrolled 60 patients in the United States and is completed.

How many patients were enrolled in the itraconazole trial?

The Phase 3 trial of itraconazole, NCT00002159, enrolled 60 patients. Participants were 13 years of age and older, of all sexes, and were not healthy volunteers. The study was conducted in the United States and is now completed.