A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

Completed · Not applicable

Conditions studied: HIV Infections, Histoplasmosis

In brief

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.

Key facts

Study ID

NCT00002438

Run by

Janssen, LP

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• HIV infection.
• Residence in an area endemic for H. capsulatum.
• Absolute CD4 count < 150 cells/mm3.
• No current or past active histoplasmosis.
• No other active fungal infection.
• Life expectancy of at least 1 year.

You may not qualify if…

• 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:
• Excluded:
• 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.

Where it is running

• Infectious Diseases Research Clinic / Indiana Univ Hosp — Indianapolis, Indiana, United States
• Infectious Diseases of Indianapolis — Indianapolis, Indiana, United States
• Univ of Missouri at Kansas City School of Medicine — Kansas City, Missouri, United States
• Infectious Diseases Association / Research Med Ctr — Kansas City, Missouri, United States
• ASCC — Memphis, Tennessee, United States
• Dr Michael Threikeld — Memphis, Tennessee, United States
• Dr Mark A Pierce — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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