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 May 14, 2025
Completed
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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