NCT00000627

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

November 1, 1994

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 26, 2021

Conditions

HIV InfectionsHistoplasmosis

Keywords

Pilot ProjectsHistoplasmosisDrug EvaluationFluconazoleAcquired Immunodeficiency SyndromeRecurrence

Interventions

FluconazoleDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Corticosteroids for up to 21 days at doses no greater than 20 mg/day prednisone (higher doses may be given for shorter durations, if clinically indicated).
  • Zidovudine, oral contraceptives, methadone, narcotics, acyclovir, acetaminophen, sulfonamides, trimethoprim/sulfamethoxazole, pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis, topical antifungals, pyrimethamine, ganciclovir.
  • Didanosine (ddI), dideoxycytidine (ddC), foscarnet, or other investigational drugs considered to be essential for patient management.
  • Concurrent Treatment:
  • Allowed:
  • Transfusion.
  • Patients must have the following:
  • HIV infection.
  • Histoplasmosis.
  • Appropriate consent must be obtained from a parent or legal guardian for patients less than 18 years of age.
  • Allowed:
  • Hematologic and/or renal laboratory abnormalities.
  • Concurrent malignancies.
  • +10 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Allergy to, or intolerance of, imidazoles or azoles.
  • Active hepatitis (viral, drug induced, or other).
  • Fungal infections for which the study drug is not indicated (e.g., aspergillosis, mucormycosis).
  • CNS/CSF culture positive for pathogens other than H. capsulatum. If C. neoformans is subsequently identified and the patient is improving, the patient may be allowed to remain on study with the permission of the protocol chair.
  • Concurrent Medication:
  • Excluded:
  • Corticosteroid use for \> 21 days at \> 20 mg/day of prednisone.
  • Systemic antifungals.
  • Prior Medication:
  • Excluded:
  • Amphotericin B at \> 2.5 mg/kg for the current episode of histoplasmosis within 7 days prior to enrollment.
  • Suppressive treatment for histoplasmosis or other fungal infections with \> 200 mg/day of ketoconazole, fluconazole, or itraconazole, or more than 50 mg amphotericin B twice weekly.
  • Risk Behavior:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

San Francisco Veterans Administration Med Ctr

San Francisco, California, 94121, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, 46202, United States

Location

Baystate Med Ctr of Springfield

Springfield, Massachusetts, 01199, United States

Location

Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial

Worcester, Massachusetts, 01605, United States

Location

Univ of Missouri at Kansas City School of Medicine

Kansas City, Missouri, 641082792, United States

Location

Infectious Diseases Association / Research Med Ctr

Kansas City, Missouri, 64132, United States

Location

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, 63112, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10025, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Montefiore Family Health Ctr / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Samaritan Village Inc / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Montefiore Med Ctr / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

North Central Bronx Hosp / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Houston Veterans Administration Med Ctr

Houston, Texas, 77030, United States

Location

Univ TX Health Science Ctr

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Wheat J, Vanden Bossche H, Marichal P. Mechanism for resistance of Histoplasma capsulatum to fluconazole. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:157

    BACKGROUND

  • Wheat J, MaWhinney S, Hafner R, McKinsey D, Chen D, Korzun A, Shakan KJ, Johnson P, Hamill R, Bamberger D, Pappas P, Stansell J, Koletar S, Squires K, Larsen RA, Cheung T, Hyslop N, Lai KK, Schneider D, Kauffman C, Saag M, Dismukes W, Powderly W. Treatment of histoplasmosis with fluconazole in patients with acquired immunodeficiency syndrome. National Institute of Allergy and Infectious Diseases Acquired Immunodeficiency Syndrome Clinical Trials Group and Mycoses Study Group. Am J Med. 1997 Sep;103(3):223-32. doi: 10.1016/s0002-9343(97)00151-4.

    PMID: 9316555BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHistoplasmosisAcquired Immunodeficiency SyndromeRecurrence

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycosesBacterial Infections and MycosesSlow Virus DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wheat LJ

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

November 1, 1994

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations

US(23)