A Phase 1 interventional study of Lobradimil and Amphotericin B in Meningitis, Cryptococcal and HIV Infections, sponsored by Alkermes, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Alkermes, Inc. · Phase 1, Interventional, and Treatment
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.
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
Browse Meningitis, Cryptococcal studies →Alkermes, Inc. is the lead sponsor of 83 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is completed, as verified in Dec 1994. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amphotericin B