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

Primary Purpose

Meningitis, Cryptococcal, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SCH 39304
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring Sch 39304, AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Evaluation, Antifungal Agents, Acquired Immunodeficiency Syndrome

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Veterans Administration Med Ctr
  • Dr Robert Larsen
  • Univ of California / San Diego Treatment Ctr
  • San Francisco AIDS Clinic / San Francisco Gen Hosp
  • George Washington Univ Med Ctr
  • Emory Univ School of Medicine
  • Med College of Georgia
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Indiana Univ Hosp
  • Tulane Univ School of Medicine
  • Univ Hosp
  • St Louis Regional Hosp / St Louis Regional Med Ctr
  • Bronx Veterans Administration / Mount Sinai Hosp
  • Erie County Med Ctr
  • Beth Israel Med Ctr
  • Mount Sinai Med Ctr
  • Univ of Rochester Medical Center
  • Univ of North Carolina
  • Duke Univ Med Ctr
  • Holmes Hosp / Univ of Cincinnati Med Ctr
  • Univ Hosp of Cleveland / Case Western Reserve Univ
  • Ohio State Univ Med Ctr
  • Buckley Braffman Stern Med Associates
  • Julio Arroyo
  • Houston Veterans Administration Med Ctr
  • Univ TX Health Science Ctr
  • Audie L Murphy Veterans Administration Hosp
  • Richmond AIDS Consortium

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00000677
Brief Title
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
Official Title
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Schering-Plough

4. Oversight

5. Study Description

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 treatment of acute disease are also evaluated. 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 against a wide range of systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it might be of value in the treatment of cryptococcal meningitis.
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. 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 against a wide range of systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it might be of value in the treatment of cryptococcal meningitis. HIV-infected patients with a diagnosis of acute cryptococcal meningitis, previously untreated or relapsed following a successfully treated acute episode, are enrolled in the study. SCH 39304 is administered orally once daily for 3 days followed by a lower dose once daily for 12 weeks. Patients who respond to primary therapy are randomized to receive SCH 39304 maintenance therapy at a higher dose once weekly or at the lower dose once daily for up to 12 months under this protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Cryptococcal, HIV Infections
Keywords
Sch 39304, AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Evaluation, Antifungal Agents, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SCH 39304

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WG Powderly
Official's Role
Study Chair
Facility Information:
Facility Name
Birmingham Veterans Administration Med Ctr
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Dr Robert Larsen
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Emory Univ School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Univ Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
St Louis Regional Hosp / St Louis Regional Med Ctr
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Bronx Veterans Administration / Mount Sinai Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Erie County Med Ctr
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Holmes Hosp / Univ of Cincinnati Med Ctr
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Univ Hosp of Cleveland / Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State Univ Med Ctr
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Houston Veterans Administration Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ TX Health Science Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Audie L Murphy Veterans Administration Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1588494
Citation
Lee BL, Padula AM, Tauber MG, Chambers HF, Sande MA. Oral SCH 39304 as primary, salvage, and maintenance therapy for cryptococcal meningitis in AIDS. J Acquir Immune Defic Syndr (1988). 1992;5(6):600-4.
Results Reference
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SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy

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