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A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

Primary Purpose

Meningitis, Cryptococcal, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, Acquired Immunodeficiency Syndrome

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Antiviral therapy (e.g., zidovudine). Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). Concurrent Treatment: Allowed: Radiation therapy for mucocutaneous Kaposi's sarcoma. Patients must be oriented to person, place, and time and able to give written informed consent. Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of cryptococcus from lumbar cerebrospinal fluid (CSF) culture within 4 months of study entry. Adequate therapy will consist of 6 - 16 weeks of treatment with amphotericin B alone, amphotericin B + oral flucytosine, or a period of the combination followed by amphotericin alone. Adequate regimens will include: A minimum total amphotericin B dose of 2 grams as monotherapy. 6 weeks of flucytosine at 150 mg/kg/day (or levels of 20 to 100 mcg/ml demonstrated) plus amphotericin B at an average daily dose of at least 0.3 mg/kg/day or to a total dose of 1 gram. After a shorter period of the combination amphotericin/flucytosine therapy, an additional Y grams of amphotericin B monotherapy will make therapy adequate where Y = 2 gm-(X weeks combination therapy / 3 weeks). For example, a patient who received 3 weeks of combination followed by amphotericin alone would need an additional 2 gm - 3 weeks/3 weeks = 1 gm of amphotericin B. Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 3 weeks of cessation of primary amphotericin B therapy. Prior Medication: Allowed: Antiviral therapy (e.g., zidovudine (AZT)). Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease. Concurrent Medication: Excluded: Intrathecal amphotericin B. Coumarin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Concurrent Treatment: Excluded: Lymphocyte replacement. Patients with the following are excluded: Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease defined by specific lab values. Inability to take oral medications reliably. Prior Medication: Excluded: Intrathecal amphotericin B. Coumarin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Prior Treatment: Excluded: Lymphocyte replacement.

Sites / Locations

  • Dr Robert Larsen
  • UCI Med Ctr
  • UCSD
  • Dr Paul Rothman
  • Stanford Univ School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00002294
Brief Title
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS
Official Title
Double Blind Placebo Controlled Study of Fluconazole (UK-49,858) for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 1989
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
Pfizer

4. Oversight

5. Study Description

Brief Summary
To compare the safety and effectiveness of fluconazole with that of placebo as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Cryptococcal, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antiviral therapy (e.g., zidovudine). Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). Concurrent Treatment: Allowed: Radiation therapy for mucocutaneous Kaposi's sarcoma. Patients must be oriented to person, place, and time and able to give written informed consent. Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of cryptococcus from lumbar cerebrospinal fluid (CSF) culture within 4 months of study entry. Adequate therapy will consist of 6 - 16 weeks of treatment with amphotericin B alone, amphotericin B + oral flucytosine, or a period of the combination followed by amphotericin alone. Adequate regimens will include: A minimum total amphotericin B dose of 2 grams as monotherapy. 6 weeks of flucytosine at 150 mg/kg/day (or levels of 20 to 100 mcg/ml demonstrated) plus amphotericin B at an average daily dose of at least 0.3 mg/kg/day or to a total dose of 1 gram. After a shorter period of the combination amphotericin/flucytosine therapy, an additional Y grams of amphotericin B monotherapy will make therapy adequate where Y = 2 gm-(X weeks combination therapy / 3 weeks). For example, a patient who received 3 weeks of combination followed by amphotericin alone would need an additional 2 gm - 3 weeks/3 weeks = 1 gm of amphotericin B. Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 3 weeks of cessation of primary amphotericin B therapy. Prior Medication: Allowed: Antiviral therapy (e.g., zidovudine (AZT)). Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease. Concurrent Medication: Excluded: Intrathecal amphotericin B. Coumarin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Concurrent Treatment: Excluded: Lymphocyte replacement. Patients with the following are excluded: Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease defined by specific lab values. Inability to take oral medications reliably. Prior Medication: Excluded: Intrathecal amphotericin B. Coumarin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Prior Treatment: Excluded: Lymphocyte replacement.
Facility Information:
Facility Name
Dr Robert Larsen
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Dr Paul Rothman
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Stanford Univ School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

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