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

Primary Purpose

Meningitis, Cryptococcal, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amphotericin B, Lipid-based
Amphotericin B
Sponsored by
Liposome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring Meningitis, Liposomes, Cryptococcosis, Acquired Immunodeficiency Syndrome, Amphotericin B, Chemistry, Pharmaceutical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harbor - UCLA Med Ctr
  • Dr Thomas Patterson
  • Walter Reed Army Med Ctr
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Natl Naval Med Ctr
  • Univ Hosp
  • East Orange Veterans Administration Med Ctr
  • Saint Michael's Med Ctr
  • Beth Israel Med Ctr / Peter Krueger Clinic
  • Dr Dorothy Friedberg
  • New York Univ Med Ctr
  • Cornell Univ Med College
  • Saint Luke's - Roosevelt Hosp Ctr
  • Mount Sinai Med Ctr / Jack Martin Fund Clinic
  • Mount Sinai Med Ctr
  • Buckley Braffman Stern Med Associates
  • Univ TX Galveston Med Branch
  • Audie L Murphy Veterans Administration Hosp
  • Univ of Utah School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Liposome
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1. Study Identification

Unique Protocol Identification Number
NCT00002019
Brief Title
Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Official Title
Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Liposome

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Cryptococcal, HIV Infections
Keywords
Meningitis, Liposomes, Cryptococcosis, Acquired Immunodeficiency Syndrome, Amphotericin B, Chemistry, Pharmaceutical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amphotericin B, Lipid-based
Intervention Type
Drug
Intervention Name(s)
Amphotericin B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Dr Thomas Patterson
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Walter Reed Army Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
203075001
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Natl Naval Med Ctr
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Univ Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
East Orange Veterans Administration Med Ctr
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Saint Michael's Med Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Beth Israel Med Ctr / Peter Krueger Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Dr Dorothy Friedberg
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cornell Univ Med College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Mount Sinai Med Ctr / Jack Martin Fund Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Audie L Murphy Veterans Administration Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Univ of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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Learn more about this trial

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

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