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Sponsored by: |
Janssen, LP |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002438 |
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.
Condition | Intervention |
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HIV Infections Histoplasmosis |
Drug: Itraconazole |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Safety Study |
Official Title: | Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
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:
Excluded within 15 days prior to study entry:
United States, Indiana | |
Infectious Diseases of Indianapolis | |
Indianapolis, Indiana, United States, 46280 | |
Infectious Diseases Research Clinic / Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 46202 | |
United States, Missouri | |
Univ of Missouri at Kansas City School of Medicine | |
Kansas City, Missouri, United States, 64108 | |
Infectious Diseases Association / Research Med Ctr | |
Kansas City, Missouri, United States, 64132 | |
United States, Tennessee | |
ASCC | |
Memphis, Tennessee, United States, 38103 | |
Dr Mark A Pierce | |
Nashville, Tennessee, United States, 37232 | |
Dr Michael Threikeld | |
Memphis, Tennessee, United States, 38105 |
Study ID Numbers: | 235B, MSG 28, ITR-USA-73 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002438 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Itraconazole Histoplasmosis Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases, Viral Clotrimazole Miconazole Histoplasmosis Acquired Immunodeficiency Syndrome Tioconazole Itraconazole Hydroxyitraconazole |
Immunologic Deficiency Syndromes Virus Diseases Mycoses HIV Infections Antifungal Agents Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents Communicable Diseases Antiprotozoal Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Histoplasmosis Hydroxyitraconazole Itraconazole Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Mycoses Antiparasitic Agents HIV Infections Therapeutic Uses Antifungal Agents Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |