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

Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002438
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histoplasmosis, HIV Infections

Keywords

Itraconazole, Histoplasmosis, Acquired Immunodeficiency Syndrome

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.

Interventions

DRUGItraconazole

Sponsors

Janssen, LP
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

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: 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. * Rifabutin. * Terfenadine. * Astemizole. * Phenobarbital. * Phenytoin. * Carbamazepine.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026