You are here

Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
UCLA CARE Ctr
Los Angeles, California, 90095 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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- HIV infection documented by antibody (ELISA on two occasions or ELISA with Western
blot confirmation), p24 antigen testing, or recovery of HIV in culture.

Prior Medication:

Required:

- Minimum total dose of 15 mg/kg of amphotericin B (either alone or in combination with
flucytosine) during primary therapy. End of primary therapy within 6 weeks of start of
maintenance therapy.

- Allowed:

- Past or present antiviral therapy and prophylaxis for Pneumocystis carinii pneumonia
(PCP).

- Pfizer must be notified if the patient is receiving ganciclovir at entry. Allowed with
amphotericin B to treat or prevent side effects.

- Antipyretics.

- Hydrocortisone.

- Meperidine.

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:

- Clinical evidence of acute or chronic meningitis other than cryptococcosis.

- Allergy or intolerance of imidazoles, azoles, or amphotericin B. Unable to take oral
medications reliably.

Patients with the following are excluded:

- Clinical evidence of acute or chronic meningitis other than cryptococcosis.

- Allergy or intolerance of imidazoles, azoles, or amphotericin B.

Prior Medication:

Excluded for more than 7 days after initiation of primary therapy for cryptococcosis:

- Ketoconazole.

- Fluconazole.

- Itraconazole.

- Miconazole.

- Any other systemic imidazole or azole.

- Excluded:

- Intrathecal amphotericin B.

- Coumadin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drug or approved (licensed) drugs for investigational indications.

Prior Treatment:

Excluded:

- Lymphocyte replacement.

NCT00001017
Pfizer
Completed
Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS

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.

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