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A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
NCT00002438 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Itraconazole
Study Locations (7)
Tennessee
- ASCC — Memphis
- Dr Michael Threikeld — Memphis
- Dr Mark A Pierce — Nashville
Indiana
- Infectious Diseases Research Clinic / Indiana Univ Hosp — Indianapolis
- Infectious Diseases of Indianapolis — Indianapolis
Missouri
- Univ of Missouri at Kansas City School of Medicine — Kansas City
- Infectious Diseases Association / Research Med Ctr — Kansas City
Trial Details
| Field | Value |
|---|---|
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002438
The ClinicalTrials.gov registry entry for NCT00002438 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Janssen, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention — of which Itraconazole is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00002438 reports 7 study locations spanning 3 distinct geographic areas — top geographies include Tennessee, Indiana, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00002438 about?
NCT00002438 is a clinical study titled "A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients". 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 infection...
What is the current status of trial NCT00002438?
This trial is currently completed. It is a NA study.
What conditions does trial NCT00002438 study?
This clinical trial studies the following conditions: HIV Infections, Histoplasmosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00002438?
The interventions under investigation include: Itraconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00002438?
This trial is sponsored by Janssen, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00002438 being conducted?
This trial has 7 study locations across Indiana, Missouri, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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