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

Alkermes

Status and phase: Completed; Phase 1

Conditions: Meningitis, Cryptococcal; HIV Infections

Treatments: Drug: Amphotericin B; Drug: Lobradimil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002316

ALK01-006

131A

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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.

Exclusion Criteria

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.