Search / Trial NCT00000975

A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Aids Related Opportunistic Infections Histoplasmosis Drug Evaluation Antifungal Agents Acquired Immunodeficiency Syndrome

Description

Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears eff...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Vincristine, vinblastine, bleomycin, or interferon for Kaposi's sarcoma.
  • Erythropoietin.
  • Didanosine by exemption for 10 patients.
  • Barbiturates.
  • Coumarin-type anticoagulants.
  • Oral contraceptives.
  • Digoxin.
  • Methadone.
  • Narcotics.
  • Acyclovir.
  • Acetaminophen.
  • Sulfonamides.
  • Trimethoprim / sulfamethoxazole.
  • Pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis.
  • Topical antifungals.
  • Pyrimethamine.
  • Ganciclovir.
  • AZT.
  • Stress doses of steroids in patients with adrenal insufficiency.
  • Concurrent Treatment:
  • Allowed:
  • Dose reduction or interruption of myelosuppressive therapy and transfusion to maintain hemoglobin of 7 or more g/dl.
  • Radiation therapy.
  • Patient must:
  • Show laboratory evidence of HIV infection and disseminated histoplasmosis.
  • Be oriented to person, place, and time.
  • Be able to give written informed consent (appropriate consent must be obtained from a parent or legal guardian for patients under 18 years of age).
  • Allowed:
  • Abnormal liver function tests in Grade 3 toxicity range if liver biopsy shows evidence that histoplasmosis caused these abnormalities.
  • Mucocutaneous candidiasis.
  • Prior Medication:
  • Allowed:
  • Amphotericin B or ketoconazole for pulmonary histoplasmosis at least 3 months prior to study entry.
  • Azidothymidine (AZT).
  • Vincristine, vinblastine, bleomycin, or interferon for mucocutaneous Kaposi's sarcoma.
  • Prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Severely ill, or at risk of dying from histoplasmosis within the first week of treatment, as indicated by systolic blood pressure less than 90 mm Hg , or PO2 less than 60.
  • Active CNS lesions, malignancies, or infections other than MAI.
  • Severe malabsorption syndrome (persistent diarrhea more than 4 weeks duration with at least 4 loose stools per day accompanied by a 10 percent or greater weight loss).
  • Requiring cytotoxic therapy for malignancies.
  • Any systemic fungal infection other than histoplasmosis.
  • Systemic Mycobacterium avium intracellulare.
  • Receiving treatment for other acute opportunistic infections whose signs and symptoms have not yet resolved or stabilized.
  • History of allergy to or intolerance of imidazoles or azoles.
  • Concurrent Medication:
  • Excluded:
  • All other systemic antifungal agents.
  • Investigational drugs not specifically allowed.
  • Oral hypoglycemics.
  • Rifamycins.
  • Phenytoin.
  • Carbamazepine.
  • Steroids in excess of physiologic replacement doses not specifically allowed.
  • Cytotoxic chemotherapy.
  • Discouraged:
  • Antacids.
  • Sucralfate.
  • H2 blockers.
  • Patients with the following are excluded:
  • Severely ill, or at risk of dying from histoplasmosis within the first week of treatment.
  • Active CNS infections, malignancies or lesions not documented to be caused by histoplasmosis, which would interfere with assessment of response.
  • Unable to take oral medications reliably.
  • Severe malabsorption syndrome.
  • Requiring cytotoxic therapy for malignancies.
  • Any systemic fungal infection other than histoplasmosis.
  • Systemic Mycobacterium avium intracellulare.
  • Receiving treatment for other acute opportunistic infections whose signs and symptoms have not yet resolved or stabilized.
  • Prior Medication:
  • Excluded for greater than 1 week within the last 3 months:
  • Fluconazole.
  • Itraconazole.
  • SCH 39304.
  • Amphotericin B greater than 1.5 mg/kg, or any other antifungal for this episode of disseminated histoplasmosis.
  • Patients who the investigator feels would be undependable with regard to adherence to the protocol.

Attachments

readout_NCT00000975_2023-11-28.pdf

4.5 MB

NCT00000975_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

New York, New York, United States

Rochester, New York, United States

Durham, North Carolina, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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