Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkermes, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Concurrent Medication:
Allowed:
Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis.
Patients must have:
HIV infection.
Acute cryptococcal meningitis.
You may not be if
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Cardiovascular disorders including congestive heart failure, uncontrolled hypertension (seated diastolic blood pressure \> 95 mm Hg), or symptomatic ischemic heart disease (angina).
Orthostatic hypotension, defined as a decrease in systolic blood pressure of \>= 20 mm Hg upon standing.
Coma.
Other CNS disease (e.g., other intracranial infections) that may interfere with assessment of response.
Opening CSF pressure \>= 350 mm or papilledema. (For patients with recurrent disease, evidence of mass effect on either MRI or CT excludes.)
Any concurrent disease that would preclude participation in the study.
Patients with the following prior conditions are excluded:
History of any bleeding disorder.
History of active renal or hepatic disease.
Myocardial infarction within the previous 3 months.
Stroke within the previous 3 months.
Clareo Health | The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
