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A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

Last updated on March 25, 2018

FOR MORE INFORMATION
Study Location
Dr Robert Larsen
Los Angeles, California, 90033 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:

- Antiviral therapy (e.g., zidovudine).

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

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 from lumbar cerebrospinal fluid (CSF)
culture within 4 months of study entry.

- Adequate therapy will consist of 6 - 16 weeks of treatment with amphotericin B alone,
amphotericin B + oral flucytosine, or a period of the combination followed by
amphotericin alone. Adequate regimens will include:

- A minimum total amphotericin B dose of 2 grams as monotherapy.

- 6 weeks of flucytosine at 150 mg/kg/day (or levels of 20 to 100 mcg/ml demonstrated)
plus amphotericin B at an average daily dose of at least 0.3 mg/kg/day or to a total
dose of 1 gram.

- After a shorter period of the combination amphotericin/flucytosine therapy, an
additional Y grams of amphotericin B monotherapy will make therapy adequate where Y =
2 gm-(X weeks combination therapy / 3 weeks).

- For example, a patient who received 3 weeks of combination followed by amphotericin
alone would need an additional 2 gm - 3 weeks/3 weeks = 1 gm of amphotericin B.

- Patients need not be receiving amphotericin B at the time of randomization but must
begin study maintenance therapy within 3 weeks of cessation of primary amphotericin B
therapy.

Prior Medication:

Allowed:

- Antiviral therapy (e.g., 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:

- 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 defined by specific lab values.

- Inability to take oral medications reliably.

Prior Medication:

Excluded:

- Intrathecal amphotericin B.

- Coumarin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

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

Prior Treatment:

Excluded:

- Lymphocyte replacement.

NCT00002294
Pfizer
Completed
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

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A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS
Double Blind Placebo Controlled Study of Fluconazole (UK-49,858) for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
To compare the safety and effectiveness of fluconazole with that of placebo as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.
Not Provided
Interventional
Not Provided
Masking: Double
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:

  • Antiviral therapy (e.g., zidovudine).
  • Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).

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 from lumbar cerebrospinal fluid (CSF) culture within 4 months of study entry.
  • Adequate therapy will consist of 6 - 16 weeks of treatment with amphotericin B alone, amphotericin B + oral flucytosine, or a period of the combination followed by amphotericin alone. Adequate regimens will include:
  • A minimum total amphotericin B dose of 2 grams as monotherapy.
  • 6 weeks of flucytosine at 150 mg/kg/day (or levels of 20 to 100 mcg/ml demonstrated) plus amphotericin B at an average daily dose of at least 0.3 mg/kg/day or to a total dose of 1 gram.
  • After a shorter period of the combination amphotericin/flucytosine therapy, an additional Y grams of amphotericin B monotherapy will make therapy adequate where Y = 2 gm-(X weeks combination therapy / 3 weeks).
  • For example, a patient who received 3 weeks of combination followed by amphotericin alone would need an additional 2 gm - 3 weeks/3 weeks = 1 gm of amphotericin B.
  • Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 3 weeks of cessation of primary amphotericin B therapy.

Prior Medication:

Allowed:

  • Antiviral therapy (e.g., 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:

  • 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 defined by specific lab values.
  • Inability to take oral medications reliably.

Prior Medication:

Excluded:

  • Intrathecal amphotericin B.
  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.

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
 
 
NCT00002294
012A
056-114A
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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