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| Sponsor: | Liposome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002019 |
Purpose
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 | Intervention |
|---|---|
|
Meningitis, Cryptococcal HIV Infections |
Drug: Amphotericin B, Lipid-based Drug: Amphotericin B |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 4 weeks of study entry:
Contacts and Locations| United States, California | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Connecticut | |
| Dr Thomas Patterson | |
| New Haven, Connecticut, United States, 06510 | |
| United States, District of Columbia | |
| Walter Reed Army Med Ctr | |
| Washington, District of Columbia, United States, 203075001 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Natl Naval Med Ctr | |
| Bethesda, Maryland, United States, 20889 | |
| United States, Massachusetts | |
| Univ Hosp | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New Jersey | |
| East Orange Veterans Administration Med Ctr | |
| East Orange, New Jersey, United States, 07018 | |
| Saint Michael's Med Ctr | |
| Newark, New Jersey, United States, 07102 | |
| United States, New York | |
| Mount Sinai Med Ctr / Jack Martin Fund Clinic | |
| New York, New York, United States, 10029 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| Dr Dorothy Friedberg | |
| New York, New York, United States, 10016 | |
| New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Cornell Univ Med College | |
| New York, New York, United States, 10021 | |
| Beth Israel Med Ctr / Peter Krueger Clinic | |
| New York, New York, United States, 10003 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, Pennsylvania | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
| Audie L Murphy Veterans Administration Hosp | |
| San Antonio, Texas, United States, 78284 | |
| United States, Utah | |
| Univ of Utah School of Medicine | |
| Salt Lake City, Utah, United States, 84132 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002019 History of Changes |
| Other Study ID Numbers: | 051A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Meningitis Liposomes Cryptococcosis |
Acquired Immunodeficiency Syndrome Amphotericin B Chemistry, Pharmaceutical |
|
HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Meningitis Meningitis, Cryptococcal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Central Nervous System Infections Central Nervous System Diseases |
Nervous System Diseases Meningitis, Fungal Central Nervous System Fungal Infections Mycoses Cryptococcosis Amphotericin B Liposomal amphotericin B Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents |