Search / Trial NCT00000992

A Study of Itraconazole in Preventing the Return 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 June 13, 2024

Completed

Keywords

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

Description

Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurr...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Itraconazole therapy must begin no more than 6 weeks after discontinuing primary amphotericin B therapy; itraconazole therapy may begin immediately after stopping the primary therapy with amphotericin B.
  • Allowed:
  • Oral contraceptives.
  • Methadone.
  • Narcotics.
  • Acyclovir.
  • Acetaminophen.
  • Sulfonamides.
  • Trimethoprim / sulfamethoxazole.
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis (patients with a total CD4+ count < 200 or a history of PCP should receive PCP prophylaxis).
  • Treatment IND drugs.
  • Zidovudine.
  • Topical antifungals.
  • Discouraged:
  • Antacids.
  • Sucralfate.
  • H2 blockers.
  • Concurrent Treatment:
  • Allowed:
  • Radiation therapy for mucocutaneous Kaposi's sarcoma.
  • Prior Medication:
  • Required:
  • Prior treatment with amphotericin B for disseminated histoplasmosis:
  • minimum total dose of 15 mg/kg for patients < 67 kg, or 1 g for patients > 67 kg; must have been administered over 6 months or less.
  • Allowed:
  • Amphotericin B as maintenance therapy for a maximum of 6 weeks following completion of primary therapy.
  • Zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions are excluded:
  • History of allergy to, or intolerance of, imidazoles or azoles.
  • Clinical findings of active histoplasmosis.
  • Histoplasmosis of the central nervous system.
  • Inability to take oral medications reliably or severe malabsorption syndrome.
  • Malignancies requiring cytotoxic therapy.
  • Culture-proven systemic Mycobacterium tuberculosis, Mycobacterium avium-intracellulare, coccidioidomycosis, or cryptococcosis.
  • Concurrent Medication:
  • Excluded:
  • Amphotericin B as maintenance therapy.
  • Immunostimulants.
  • Ketoconazole.
  • Systemic antifungals.
  • Steroids in excess of physiologic replacement doses.
  • Cytotoxic chemotherapy.
  • Investigational agents not specifically allowed.
  • Antacids for 4 hours before and 4 hours after itraconazole.
  • Concurrent Treatment:
  • Excluded:
  • Lymphocyte replacement.
  • Patients with the following conditions are excluded:
  • History of allergy to, or intolerance of, imidazoles or azoles.
  • Clinical findings of active histoplasmosis.
  • Histoplasmosis of the central nervous system.
  • Inability to take oral medications reliably or severe malabsorption syndrome.
  • Malignancies requiring cytotoxic therapy.
  • Culture-proven systemic Mycobacterium tuberculosis, Mycobacterium avium-intracellulare, coccidioidomycosis, or cryptococcosis.
  • Prior Medication:
  • Excluded within 30 days of study entry:
  • Immunostimulants.
  • Ketoconazole.
  • Systemic antifungals.
  • Steroids in excess of physiologic replacement doses.
  • Cytotoxic chemotherapy.
  • Prior Treatment:
  • Excluded:
  • Lymphocyte replacement.
  • Risk Behavior:
  • Excluded:
  • Patients who in the opinion of the investigator would be undependable with regard to adherence to protocol.
  • Inclusion criteria are:
  • HIV infection documented by presence of antibody, by ELISA with Western blot confirmation, or serum p24 antigen, or by recovery of HIV in culture.
  • Acute first episode of disseminated histoplasmosis documented by recovery and identification of H. capsulatum from cultures obtained from extrapulmonary sites.
  • Oriented to person, place, and time, and able to give written informed consent.

Attachments

readout_NCT00000992_2024-06-13.pdf

4.5 MB

NCT00000992_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

Saint Louis, Missouri, United States

New York, New York, United States

Cincinnati, 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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1 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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