To evaluate the safety, tolerance and efficacy of three different dosage regimens of Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B) in patients with AIDS and cryptococcal meningitis.

Condition	Treatment or Intervention
Meningitis, Cryptococcal HIV Infections	Drug: Amphotericin B, Lipid-based  Drug: Amphotericin B

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      Harbor - UCLA Med Ctr, Torrance,  California,  90502,  United States
Connecticut
      Dr Thomas Patterson, New Haven,  Connecticut,  06510,  United States
District of Columbia
      Walter Reed Army Med Ctr, Washington,  District of Columbia,  203075001,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
Maryland
      Natl Naval Med Ctr, Bethesda,  Maryland,  20889,  United States
Massachusetts
      Univ Hosp, Boston,  Massachusetts,  02118,  United States
New Jersey
      East Orange Veterans Administration Med Ctr, East Orange,  New Jersey,  07018,  United States
      Saint Michael's Med Ctr, Newark,  New Jersey,  07102,  United States
New York
      Mount Sinai Med Ctr / Jack Martin Fund Clinic, New York,  New York,  10029,  United States
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10025,  United States
      Dr Dorothy Friedberg, New York,  New York,  10016,  United States
      New York Univ Med Ctr, New York,  New York,  10016,  United States
      Cornell Univ Med College, New York,  New York,  10021,  United States
      Beth Israel Med Ctr / Peter Krueger Clinic, New York,  New York,  10003,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
Pennsylvania
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Univ TX Galveston Med Branch, Galveston,  Texas,  77550,  United States
      Audie L Murphy Veterans Administration Hosp, San Antonio,  Texas,  78284,  United States
Utah
      Univ of Utah School of Medicine, Salt Lake City,  Utah,  84132,  United States

Study ID Numbers:  051A
Record last reviewed:  November 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002019
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08