Trial | NCT00002316  Report issue

Title

The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Drug Lobradimil

Drug 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.
No Results Posted