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Sponsored by: |
Alkermes |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002316 |
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 |
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 |
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:
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 |
Study ID Numbers: | 131A, ALK01-006 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002316 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Meningitis Drug Therapy, Combination |
Antifungal Agents Acquired Immunodeficiency Syndrome Amphotericin B |
Abelcet Amphotericin B Opportunistic Infections Meningitis, Fungal Sexually Transmitted Diseases, Viral Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Tioconazole Central Nervous System Diseases Liposomal amphotericin B |
Immunologic Deficiency Syndromes Meningitis Virus Diseases Mycoses Central Nervous System Infections HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Meningitis, Cryptococcal Cryptococcosis Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Immune System Diseases Nervous System Diseases Infection Pharmacologic Actions |
Anti-Bacterial Agents Antiparasitic Agents Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Lentivirus Infections Central Nervous System Fungal Infections Amebicides |