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| Sponsored by: |
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: | Treatment, Dose Comparison, Safety Study |
| 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
| Study ID Numbers: | 051A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002019 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Meningitis Liposomes Cryptococcosis |
Acquired Immunodeficiency Syndrome Amphotericin B Chemistry, Pharmaceutical |
|
Abelcet Amphotericin B Sexually Transmitted Diseases, Viral Meningitis, Fungal Acquired Immunodeficiency Syndrome Central Nervous System Diseases Liposomal amphotericin B Immunologic Deficiency Syndromes Meningitis Virus Diseases |
Anti-Bacterial Agents Mycoses Central Nervous System Infections HIV Infections Antifungal Agents Sexually Transmitted Diseases Meningitis, Cryptococcal Central Nervous System Fungal Infections Cryptococcosis Retroviridae Infections |
|
Abelcet Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Liposomal amphotericin B Infection Meningitis Anti-Bacterial Agents Mycoses Antiparasitic Agents Pathologic Processes Antifungal Agents Therapeutic Uses Syndrome |
Antibiotics, Antifungal Meningitis, Cryptococcal Amebicides Central Nervous System Fungal Infections Retroviridae Infections Amphotericin B RNA Virus Infections Meningitis, Fungal Disease Immune System Diseases Acquired Immunodeficiency Syndrome Nervous System Diseases Central Nervous System Diseases Pharmacologic Actions Immunologic Deficiency Syndromes |