You are here

Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cryptococcal Meningitis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Concurrent Medication:

Allowed:

- Antivirals 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.

- Patient's treatment status must be one of the following:

- No prior systemic antifungal therapy for cryptococcosis.

- Relapse after prior therapy. The success of prior therapy must have been documented by
negative 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
the study.

Prior Medication:

Allowed:

- Antivirals such as zidovudine (AZT). Prophylaxis for Pneumocystis carinii pneumonia.
Aerosolized pentamidine.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Co-existing Condition:

Patients with the following are excluded:

- Evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.

- A history of allergy to or intolerance of imidazoles or azoles.

- Moderate or severe liver disease defined by specified lab values.

- Life expectancy of

Concurrent Medication:

Excluded:

- Coumarin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drugs or approved (licensed) drugs for investigational indications
except aerosolized pentamidine.

Concurrent Treatment:

Excluded:

- Lymphocyte replacement.

Patients with the following are excluded:

- Evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.

- A history of allergy to or intolerance of imidazoles or azoles.

- Moderate or severe liver disease defined by specified lab values.

- Life expectancy of

Prior Medication:

Excluded:

- Coumarin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drugs or approved (licensed) drugs for investigational indications
except aerosolized pentamidine.

Prior Treatment:

Excluded:

- Lymphocyte replacement.

NCT00002040
Pfizer
Completed
Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now