You are here

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

Last updated on February 17, 2019

FOR MORE INFORMATION
Study Location
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294 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

Concurrent Medication:

Allowed:

- Antivirals such as zidovudine.

- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia
(PCP).

- Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry.

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 neoformans from lumbar cerebrospinal
fluid (CSF) culture within 6 months prior to entry.

- Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or
in combination with flucytosine) during primary therapy.

- Patients need not be receiving amphotericin B at the time of randomization but must
begin study maintenance therapy within 6 weeks of completion of primary amphotericin B
therapy. Patients may receive maintenance amphotericin B during the period between
completion of primary therapy and study entry.

Prior Medication:

Allowed:

- Antivirals such as zidovudine (AZT).

- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia
(PCP).

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 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:

- Ketoconazole.

- Fluconazole.

- Itraconazole.

- Miconazole.

- Any systemic imidazole or azole for more than 7 days after initiation of primary
therapy for cryptococcosis.

- 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.

- Inability to take oral medications reliably.

Prior Medication:

Excluded:

- Ketoconazole.

- Fluconazole.

- Itraconazole.

- Miconazole.

- Any systemic imidazole or azole for more than 7 days after initiation of primary
therapy for cryptococcosis.

- Intrathecal amphotericin B.

- Coumarin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

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

- Any exceptions to these prohibitions of concomitant medications must be approved by
Pfizer Central Research.

Prior Treatment:

Excluded:

- Lymphocyte replacement.

NCT00002074
Pfizer
Completed
Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

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

Cryptosporidiosis, HIV Infections
NCT00002328
All Genders
0+
Years
Groton, Connecticut
Cryptococcal Meningitis, HIV Infections
NCT00002306
All Genders
13+
Years
Multiple Sites
Cryptococcal Meningitis, HIV Infections
NCT00002040
All Genders
13+
Years
Multiple Sites
Cryptococcal Meningitis, HIV Infections
NCT00002076
All Genders
13+
Years
Multiple Sites

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

Call Now