Clinical trial NCT00002076: Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Official title: Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meningitis, Cryptococcal
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Meningitis
Cryptococcosis
Fluconazole
Administration, Oral
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.
* Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

* Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

* No prior systemic antifungal therapy for cryptococcosis.
* Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.

Prior Medication:

Allowed:

* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.
* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
* Moderate or severe liver disease defined by specified lab values.
* Patients who are unable to take oral medication.
* Unlikely to survive more than 2 weeks.
* Renal impairment.

Concurrent Medication:

Excluded:

* Coumarin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
* Excluded within 4 weeks of study entry:
* Greater than 1 mg/kg/wk amphotericin B.
* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Treatment:

Excluded:

* Lymphocyte replacement.

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles or azoles.
* Moderate or severe liver disease defined by specified lab values.
* Patients who are unable to take oral medication.
* Life expectancy of \< 2 weeks.
* Any condition that may impair absorption of oral medication.

Prior Medication:

Excluded:

* Coumarin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
* Excluded within 4 weeks of study entry:
* Greater than 1 mg/kg/wk amphotericin B.

Prior Treatment:

Excluded:

* Lymphocyte replacement.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Summitt Med Ctr / San Francisco Gen Hosp
state: California
city: New York
country: United States
facility: Cornell Univ Med Ctr
state: New York
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
Study officials:
References: