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COMPLETED NA

Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome

NCT00000627 · View on ClinicalTrials.gov ↗

Study Summary

To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.

Interventions

  • DRUG Fluconazole

Study Locations (20)

New York

  • Beth Israel Med Ctr — New York
  • Cornell Univ Med Ctr — New York
  • Saint Luke's - Roosevelt Hosp Ctr — New York
  • Mount Sinai Med Ctr — New York
  • Montefiore Drug Treatment Ctr / Bronx Municipal Hosp — The Bronx
  • Montefiore Family Health Ctr / Bronx Municipal Hosp — The Bronx
  • Samaritan Village Inc / Bronx Municipal Hosp — The Bronx
  • Montefiore Med Ctr / Bronx Municipal Hosp — The Bronx
  • North Central Bronx Hosp / Bronx Municipal Hosp — The Bronx

Missouri

  • Univ of Missouri at Kansas City School of Medicine — Kansas City
  • Infectious Diseases Association / Research Med Ctr — Kansas City
  • St Louis Regional Hosp / St Louis Regional Med Ctr — St Louis

California

  • Univ of Southern California / LA County USC Med Ctr — Los Angeles
  • San Francisco Veterans Administration Med Ctr — San Francisco

Indiana

  • Indiana Univ Hosp — Indianapolis
  • Methodist Hosp of Indiana / Life Care Clinic — Indianapolis

Massachusetts

  • Baystate Med Ctr of Springfield — Springfield
  • Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial — Worcester

Alabama

  • Univ of Alabama at Birmingham — Birmingham

Ohio

  • Ohio State Univ Hosp Clinic — Columbus

Trial Details

FieldValue
Enrollment Target 90 participants
Est. Completion 1994-11
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00000627

The ClinicalTrials.gov registry entry for NCT00000627 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. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 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 Fluconazole 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: NCT00000627 reports 20 study locations spanning 7 distinct geographic areas — top geographies include New York, Missouri, California. 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 NCT00000627 about?

NCT00000627 is a clinical study titled "Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome". To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the t...

What is the current status of trial NCT00000627?

This trial is currently completed. It is a NA study. The enrollment target is 90 participants. Estimated completion is 1994-11.

What conditions does trial NCT00000627 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 NCT00000627?

The interventions under investigation include: Fluconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00000627?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00000627 being conducted?

This trial has 20 study locations across Alabama, California, Indiana, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial