Search / Trial NCT00000677

SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy

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

Sch 39304 Aids Related Opportunistic Infections Meningitis Cryptococcosis Drug Evaluation Antifungal Agents Acquired Immunodeficiency Syndrome

Description

Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority of patients. Maintenance therapy is recommended but must be balanced against the multiple toxicities of the drugs used and the problems associated with the weekly administration of intravenous therapy. Treatments that are equally or more effective and less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an orally active antifungal drug that in animal studies is active agains...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Currently approved antiviral therapy.
  • Maintenance therapy for cytomegalovirus retinitis or toxoplasmosis.
  • Rifampin.
  • Isoniazid.
  • Dilantin or barbiturates if investigator agrees to rigorously monitor anticonvulsant drug levels.
  • Coumarin-type anticoagulants if investigator agrees to rigorously monitor prothrombin time.
  • Prophylactic treatment for Pneumocystis carinii pneumonia (PCP).
  • Concurrent Treatment:
  • Allowed:
  • Local radiotherapy for mucocutaneous Kaposi's sarcoma.
  • Prior Medication:
  • Allowed:
  • Amphotericin B, up to 1 mg/kg, during the previous 7 days.
  • Patients must be HIV positive by 2 methodologies and have either primary cryptococcal meningitis with no prior anti-cryptococcal therapy or relapsed disease after prior therapy.
  • Prior therapy for cryptococcal meningitis is limited to approved drugs.
  • Written informed consent either from patient or patient's parent or legal guardian is required.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • History of hypersensitivity to imidazole or azole compounds.
  • Central nervous system disease.
  • Acute opportunistic infection.
  • Underlying conditions that in the opinion of the investigator could preclude assessment of response.
  • Concurrent Medication:
  • Excluded:
  • Systemic antifungal drugs other than study drug.
  • Any investigational drug other than treatment IND drugs.
  • Oral hypoglycemic agents.
  • Oral contraceptives.
  • Cytotoxic chemotherapy.
  • Patients with the following are excluded:
  • Unable to take oral medications.
  • Concurrent central nervous system disease which in opinion of investigator would interfere with assessment of response.
  • Concurrent acute opportunistic infection requiring therapy (patients who develop an acute opportunistic infection after initiation of study medication may remain on study medication).
  • Prior Medication:
  • Excluded within 7 days of study entry:
  • Amphotericin B, > 1 mg/kg.

Attachments

readout_NCT00000677_2024-06-13.pdf

4.5 MB

NCT00000677_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

Indianapolis, Indiana, United States

New York, New York, United States

New York, New York, United States

West Columbia, South Carolina, United States

Houston, Texas, United States

Houston, Texas, United States

Chicago, Illinois, United States

Richmond, Virginia, United States

San Diego, California, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

San Francisco, California, United States

New Orleans, Louisiana, United States

Washington, District Of Columbia, United States

Bronx, New York, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Boston, Massachusetts, United States

St Louis, Missouri, United States

Buffalo, New York, United States

Columbus, Ohio, United States

San Antonio, Texas, 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

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

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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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