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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002077
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1989
  Purpose

To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS patients. Lack of satisfactory response will allow increase of dose. Both newly diagnosed and relapsed patients are eligible.


Condition Intervention
Meningitis, Cryptococcal
HIV Infections
Drug: Fluconazole

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antivirals such as zidovudine (AZT).
  • Prophylaxis for Pneumocystis carinii pneumonia (including 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 (including 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.
  • A history of allergy to or intolerance of imidazoles or azoles.
  • Moderate or severe liver disease defined by specified lab values.
  • Life expectancy of < 2 weeks.

Concurrent Medication:

Excluded:

  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications other than 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 < 2 weeks.

Prior Medication:

Excluded:

  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.

Prior Treatment:

Excluded:

  • Lymphocyte replacement.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002077

Locations
United States, Illinois
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, New Jersey
Saint Michael's Med Ctr
Newark, New Jersey, United States, 07102
United States, New York
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Cabrini Med Ctr
New York, New York, United States, 10003
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002077     History of Changes
Other Study ID Numbers: 012K, 056-164
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Meningitis
Injections, Intravenous
Cryptococcosis
Fluconazole
Administration, Oral
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Meningitis
Meningitis, Cryptococcal
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 09, 2014