Search / Trial NCT00002294

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

Launched by PFIZER · Aug 30, 2001

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Trial Information

Current as of December 06, 2024

Completed

Keywords

Aids Related Opportunistic Infections Meningitis Cryptococcosis Fluconazole Acquired Immunodeficiency Syndrome

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • • 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.

About Pfizer

Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.

Locations

San Diego, California, United States

Los Angeles, California, United States

Stanford, California, United States

Orange, California, United States

Sherman Oaks, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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