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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00002294
• Date of registration: 02/11/1999
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS
• Scientific title: Double Blind Placebo Controlled Study of Fluconazole (UK-49,858) for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
• Date of first enrolment: October 1997
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002294
• Study type: Interventional
• Study design: Masking: Double-Blind, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Meningitis, Cryptococcal

Intervention(s)

Drug: Fluconazole

Secondary ID(s)

012A

056-114A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors