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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Cook County Hosp
Chicago, Illinois, 60612 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 (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
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
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

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.

NCT00002077
Pfizer
Completed
An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

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[email protected]

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An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
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.
Not Provided
Interventional
Not Provided
Masking: None (Open Label)
Primary Purpose: Treatment
  • Meningitis, Cryptococcal
  • HIV Infections
Drug: Fluconazole
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002077
012K
056-164
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
December 1989

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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