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| Sponsored by: |
Alkermes |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002316 |
Purpose
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.
| Condition | Intervention | Phase |
|
Meningitis, Cryptococcal HIV Infections |
Drug: Lobradimil Drug: Amphotericin B |
Phase I |
| MedlinePlus related topics: | AIDS Meningitis |
| Drug Information available for: | Amphotericin B Lobradimil Clotrimazole Miconazole Miconazole nitrate Tioconazole |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
| Official Title: | Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis |
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:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and Locations| United States, California | |||||
| UCI Med Ctr | |||||
| Orange, California, United States, 92668 | |||||
| Los Angeles County - USC Med Ctr | |||||
| Los Angeles, California, United States, 90033 | |||||
| UCSD Treatment Ctr | |||||
| San Diego, California, United States, 92103 | |||||
| United States, Kansas | |||||
| Univ of Kansas School of Medicine | |||||
| Wichita, Kansas, United States, 67214 | |||||
| United States, New York | |||||
| SUNY / Health Sciences Ctr at Stony Brook | |||||
| Stony Brook, New York, United States, 117948153 | |||||
| United States, North Carolina | |||||
| Duke Univ Med Ctr | |||||
| Durham, North Carolina, United States, 27710 | |||||
| Bowman Gray School of Medicine | |||||
| Winston Salem, North Carolina, United States, 271571042 | |||||
| East Carolina Univ School of Medicine | |||||
| Greenville, North Carolina, United States, 278584354 | |||||
| United States, Ohio | |||||
| Case Western Reserve Univ | |||||
| Cleveland, Ohio, United States, 44106 | |||||
| United States, Pennsylvania | |||||
| Pennsylvania State Univ / Hershey Med Ctr | |||||
| Hershey, Pennsylvania, United States, 17033 | |||||
| United States, Texas | |||||
| Univ TX Galveston Med Branch | |||||
| Galveston, Texas, United States, 775550882 | |||||
| Alkermes |
More Information
| Study ID Numbers: | 131A, ALK01-006 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002316 |
| Health Authority: | United States: Food and Drug Administration |
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