Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Fluconazole
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.