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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002438
• Other study ID #: 235B
• Secondary ID: MSG 28ITR-USA-73
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Histoplasmosis
• HIV Infections
• Infection

Intervention

Drug:
• Itraconazole

Locations

Country	Name	City	State
United States	Infectious Diseases of Indianapolis	Indianapolis	Indiana
United States	Infectious Diseases Research Clinic / Indiana Univ Hosp	Indianapolis	Indiana
United States	Infectious Diseases Association / Research Med Ctr	Kansas City	Missouri
United States	Univ of Missouri at Kansas City School of Medicine	Kansas City	Missouri
United States	ASCC	Memphis	Tennessee
United States	Dr Michael Threikeld	Memphis	Tennessee
United States	Dr Mark A Pierce	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Janssen, LP

Country where clinical trial is conducted

United States,