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| ID | Type | Description | Link |
|---|---|---|---|
| ALK01-006 |
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To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7.
Patients receive intravenous RMP-7 added to conventional therapy with intravenous amphotericin B (with or without flucytosine). Treatment continues for 14 days, with follow-up visits 4 and 12 weeks later.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lobradimil | Drug | |||
| Amphotericin B | Drug |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | United States | ||
| UCI Med Ctr |
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| Orange |
| California |
| 92668 |
| United States |
| UCSD Treatment Ctr | San Diego | California | 92103 | United States |
| Univ of Kansas School of Medicine | Wichita | Kansas | 67214 | United States |
| SUNY / Health Sciences Ctr at Stony Brook | Stony Brook | New York | 117948153 | United States |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | United States |
| East Carolina Univ School of Medicine | Greenville | North Carolina | 278584354 | United States |
| Bowman Gray School of Medicine | Winston-Salem | North Carolina | 271571042 | United States |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | United States |
| Pennsylvania State Univ / Hershey Med Ctr | Hershey | Pennsylvania | 17033 | United States |
| Univ TX Galveston Med Branch | Galveston | Texas | 775550882 | United States |
| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| D015658 | HIV Infections |
| D017088 | AIDS-Related Opportunistic Infections |
| D008581 | Meningitis |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003453 | Cryptococcosis |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009894 | Opportunistic Infections |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| C089876 | RMP 7 |
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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