NCT00002438CompletedNot Applicable
Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Janssen, LP
- Locations
- 7
Study Overview
Brief Summary
To assess the safety and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have:
- •HIV infection.
- •Residence in an area endemic for H. capsulatum.
- •Absolute CD4 count < 150 cells/mm
- •No current or past active histoplasmosis.
- •No other active fungal infection.
- •Life expectancy of at least 1 year.
Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Life-threatening infection or malignancy other than cutaneous Kaposi's sarcoma.
- •Inability to take oral medication.
- •Concurrent Medication:
- •Systemically-active antifungals.
- •Investigational drugs (expanded access drugs are acceptable).
- •Rifampin.
- •Rifabutin.
- •Terfenadine.
- •Astemizole.
- •Phenobarbital.
- •Phenytoin.
- •Carbamazepine.
- •H2 blockers.
- •Omeprazole.
- •Continual antacids.
- •Patients with the following prior conditions are excluded:
- •History of intolerance to imidazole or azole compounds.
- •Prior Medication:
- •Excluded within 1 month prior to study entry:
- •Investigational drugs (expanded access drugs are acceptable).
- •Excluded within 15 days prior to study entry:
- •Rifampin.
- •Rifabutin.
- •Terfenadine.
- •Astemizole.
- •Phenobarbital.
- •Phenytoin.
- •Carbamazepine.
Investigators
Study Sites (7)
Loading locations...
Similar Trials
Completed
Phase 1
A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDSHistoplasmosisHIV InfectionsNCT00000992National Institute of Allergy and Infectious Diseases (NIAID)30
Completed
Phase 2
A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDSHIV InfectionsHistoplasmosisNCT00000975National Institute of Allergy and Infectious Diseases (NIAID)30
Completed
Phase 3
Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow TransplantationCancerNCT00003883Fred Hutchinson Cancer Center578
Completed
Phase 2
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of AspergillomaLung Diseases, FungalAspergillosisNCT00005668National Institute of Allergy and Infectious Diseases (NIAID)96
Completed
Not Applicable
Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.Candidiasis, EsophagealHIV InfectionsNCT00002132Janssen Pharmaceuticals