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

Last updated date
Study Location
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections, Histoplasmosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

- Concurrent infection with Mycobacteria.

- Patients with severe manifestations of histoplasmosis who are thought to be at risk of dying within one week should receive up to 250 mg amphotericin B for up to seven days prior to enrollment and then be re-evaluated. Patients who are still severely ill and do not meet eligibility criteria may not enter the study.

Specific criteria defining life-threatening histoplasmosis include:

- Systolic blood pressure < 90 mm Hg without other cause; arterial pO2 < 60 torr without other cause; and SGOT > 10 x upper limit of normal or bilirubin > 3 x upper limit of normal. Any other cases not meeting this definition must be reviewed with the protocol chair.

Prior Medication:

Allowed:

- Amphotericin B (up to 250 mg) over 7 days in patients with severe histoplasmosis.

Risk Behavior:

Allowed:

- Patients with a history of high-risk behavior for HIV infection (bisexual or homosexual men, intravenous drug abusers, recipients of blood or blood products prior to May 1985, or sexual partners of any of the foregoing).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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:


Excluded:


- Patients who the investigator feels would be undependable with regard to adherence to
the protocol.


Patients may not have the following prior conditions:


- History of allergy to, or intolerance of, imidazoles or azoles.

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HIV Infections, HistoplasmosisPilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
NCT00000627
  1. Birmingham, Alabama
  2. Los Angeles, California
  3. San Francisco, California
  4. Indianapolis, Indiana
  5. Indianapolis, Indiana
  6. Springfield, Massachusetts
  7. Worcester, Massachusetts
  8. Kansas City, Missouri
  9. Kansas City, Missouri
  10. St Louis, Missouri
  11. Bronx, New York
  12. Bronx, New York
  13. Bronx, New York
  14. Bronx, New York
  15. Bronx, New York
  16. New York, New York
  17. New York, New York
  18. New York, New York
  19. New York, New York
  20. Columbus, Ohio
  21. West Columbia, South Carolina
  22. Houston, Texas
  23. Houston, Texas
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
Official Title  ICMJE Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
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.

Detailed Description

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.

At least 40 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for the study. Patients receive fluconazole for a total of 12 weeks. Patients who are unable to take the drug orally may receive it intravenously until oral administration is possible. Patients are evaluated at weeks 0, 1, 2, 4, 8, and 12. Patients who are doing well without evidence of clinical failure or dose-limiting toxicity are permitted to continue maintenance therapy to prevent relapse at a reduced dose for an additional 12 months; those who relapse on the reduced dose are permitted to receive re-induction with a higher dose.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Histoplasmosis
Intervention  ICMJE Drug: Fluconazole
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
90
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1994
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

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.
  • Concurrent infection with Mycobacteria.
  • Patients with severe manifestations of histoplasmosis who are thought to be at risk of dying within one week should receive up to 250 mg amphotericin B for up to seven days prior to enrollment and then be re-evaluated. Patients who are still severely ill and do not meet eligibility criteria may not enter the study.

Specific criteria defining life-threatening histoplasmosis include:

  • Systolic blood pressure < 90 mm Hg without other cause; arterial pO2 < 60 torr without other cause; and SGOT > 10 x upper limit of normal or bilirubin > 3 x upper limit of normal. Any other cases not meeting this definition must be reviewed with the protocol chair.

Prior Medication:

Allowed:

  • Amphotericin B (up to 250 mg) over 7 days in patients with severe histoplasmosis.

Risk Behavior:

Allowed:

  • Patients with a history of high-risk behavior for HIV infection (bisexual or homosexual men, intravenous drug abusers, recipients of blood or blood products prior to May 1985, or sexual partners of any of the foregoing).

Exclusion Criteria

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:

Excluded:

  • Patients who the investigator feels would be undependable with regard to adherence to the protocol.

Patients may not have the following prior conditions:

  • History of allergy to, or intolerance of, imidazoles or azoles.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000627
Other Study ID Numbers  ICMJE ACTG 174
R-0245
11149 ( Registry Identifier: DAIDS ES Registry Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Wheat LJ
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP