The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis

Completed · Phase 1

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002316

Run by

Alkermes, Inc.

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCI Med Ctr — Orange, California, United States
• UCSD Treatment Ctr — San Diego, California, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• SUNY / Health Sciences Ctr at Stony Brook — Stony Brook, New York, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• East Carolina Univ School of Medicine — Greenville, North Carolina, United States
• Bowman Gray School of Medicine — Winston-Salem, North Carolina, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• Pennsylvania State Univ / Hershey Med Ctr — Hershey, Pennsylvania, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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