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...
Date First Received: November 2, 1999
Last Updated: June 23, 2005
Verified by: NIH AIDS Clinical Trials Information Service, April 1996
Clinical Trial Phase: N/A | Start Date:
Overall Status: Completed
Brief Summary
Official Title: “Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Safety Study
Intervention(s) in this Clinical Trial
- Drug: Itraconazole
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Janssen, LP
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002438
Study ID Number: 235B
ClinicalTrials.gov Identifier: NCT00002438
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
