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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002074
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.

Condition Intervention
Meningitis, Cryptococcal HIV Infections Drug: Fluconazole Drug: Amphotericin B

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002074


  Show 39 Study Locations
Sponsors and Collaborators
Pfizer
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002074     History of Changes
Other Study ID Numbers: 012D
056-157
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: May 1990

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Meningitis
Cryptococcosis
Fluconazole
Acquired Immunodeficiency Syndrome
Amphotericin B

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Meningitis
Meningitis, Cryptococcal
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Central Nervous System Infections
Fluconazole
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors