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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002019
• Other study ID #: 051A
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Amphotericin B, Lipid-based

• Amphotericin B

Locations

Country	Name	City	State
United States	Natl Naval Med Ctr	Bethesda	Maryland
United States	Univ Hosp	Boston	Massachusetts
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	East Orange Veterans Administration Med Ctr	East Orange	New Jersey
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Dr Thomas Patterson	New Haven	Connecticut
United States	Beth Israel Med Ctr / Peter Krueger Clinic	New York	New York
United States	Cornell Univ Med College	New York	New York
United States	Dr Dorothy Friedberg	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Mount Sinai Med Ctr / Jack Martin Fund Clinic	New York	New York
United States	New York Univ Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Saint Michael's Med Ctr	Newark	New Jersey
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Univ of Utah School of Medicine	Salt Lake City	Utah
United States	Audie L Murphy Veterans Administration Hosp	San Antonio	Texas
United States	Harbor - UCLA Med Ctr	Torrance	California
United States	Walter Reed Army Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Liposome

Country where clinical trial is conducted

United States, 

References & Publications (1)

al-Haddadin D, Fan-Havard P, Boghossian J, Marton R, Vincent-Graber D, Dungo L, Eng RH, Johnson ES. Amphotericin B-lipid complex (ABLC) in treatment of cryptococcal meningitis in AIDS. Int Conf AIDS. 1992 Jul 19-24;8(2):B109 (abstract no PoB 3132)