Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Schering-Plough

Conditions:

Meningitis, Cryptococcal

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE1

Brief Summary

To assess the safety and effectiveness of SCH 39304 as primary treatment of acute cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance therapy following successful...

Detailed 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. ...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00000677

Last Update

June 24 2005

Active Locations (28)

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Page 1 of 7 (28 locations)

1

Birmingham Veterans Administration Med Ctr

Birmingham, Alabama, United States, 35233

2

Dr Robert Larsen

Los Angeles, California, United States, 90033

3

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

4

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States, 941102859