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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
Est. completion date
Est. primary completion date
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


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, 

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