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A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Janssen, LP
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002438
  Purpose

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
HIV Infections
Histoplasmosis
Drug: Itraconazole

MedlinePlus related topics: AIDS Fungal Infections Molds
Drug Information available for: Itraconazole
U.S. FDA Resources
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
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002438

Locations
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
Sponsors and Collaborators
Janssen, LP
  More Information

No publications provided

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009