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Home > "A" Clinical Trials Conditions > A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS  A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
UCSD
San Diego, California, 92103
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Dr Robert Larsen
Los Angeles, California, 90033
United States
UCI Med Ctr
Orange, California, 92668
United States
Dr Paul Rothman
Sherman Oaks, California, 91403
United States
Additional Information:
Study ID Numbers: 012A; 056-114A
Study Start Date:
Record last reviewed: December 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002294
Other Hiv Infections Studies:
1. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
2. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
3. Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
4. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
5. SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Sherman Oaks Clinical Trials
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS
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