Search / Trial NCT00002019

Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome

Launched by LIPOSOME · Aug 30, 2001

Trial Information

Current as of December 27, 2024

Completed

Keywords

Meningitis Liposomes Cryptococcosis Acquired Immunodeficiency Syndrome Amphotericin B Chemistry, Pharmaceutical

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Intravenous pentamidine for treatment of Pneumocystis carinii pneumonia (PCP) but not for prophylaxis.
  • Patients must have the following:
  • Meet the CDC criteria for diagnosis of AIDS.
  • Confirmed episode of acute cryptococcal meningitis.
  • Informed consent of the patient or guardian prior to entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.
  • History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.
  • Any other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.
  • Concurrent Medication:
  • Excluded:
  • Corticosteroids.
  • Salicylates or other drugs known to interfere with prostaglandin synthesis except as specified in protocol.
  • Zidovudine.
  • Investigational agents.
  • Interferon.
  • Interleukin-2 (IL-2).
  • Steroids.
  • Isoprinosine.
  • Intrathecal Amphotericin B.
  • Intravenous Pentamidine PCP prophylaxis (only treatment).
  • Patients with the following are excluded:
  • Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.
  • History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.
  • Inability to obtain appropriate follow-up visits.
  • Any other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.
  • Prior Medication:
  • Excluded within 4 weeks of study entry:
  • Amphotericin B.
  • * Excluded within 2 weeks of study entry:
  • Any other experimental drug.

About Liposome

Liposome is a pioneering clinical trial sponsor specializing in the development and advancement of liposomal drug delivery systems. With a strong commitment to innovation in pharmaceutical formulations, Liposome focuses on enhancing the efficacy and safety of therapeutic agents through targeted delivery mechanisms. The organization collaborates with leading researchers and institutions to conduct rigorous clinical trials that assess the performance of its proprietary liposomal technologies across various therapeutic areas. Liposome's mission is to transform patient outcomes by optimizing drug absorption and minimizing side effects, thereby contributing to the future of precision medicine.

Locations

New York, New York, United States

Chicago, Illinois, United States

Newark, New Jersey, United States

New York, New York, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

Salt Lake City, Utah, United States

Boston, Massachusetts, United States

San Antonio, Texas, United States

Torrance, California, United States

New York, New York, United States

New York, New York, United States

New Haven, Connecticut, United States

Washington, District Of Columbia, United States

Bethesda, Maryland, United States

East Orange, New Jersey, United States

New York, New York, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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