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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002438
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
HIV Infections Histoplasmosis Drug: Itraconazole

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   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/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:


  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002438

United States, Indiana
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Infectious Diseases of Indianapolis
Indianapolis, Indiana, United States, 46280
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
Memphis, Tennessee, United States, 38103
Dr Michael Threikeld
Memphis, Tennessee, United States, 38105
Dr Mark A Pierce
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Janssen, LP
More Information

ClinicalTrials.gov Identifier: NCT00002438     History of Changes
Other Study ID Numbers: 235B
MSG 28
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors