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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Amphotericin B; Liposomal amphotericin B

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.