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

Sponsor

Alkermes, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00002316

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Lobradimil Drug: Amphotericin B	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033
2	UCI Med Ctr	Orange	California	United States	92668
3	UCSD Treatment Ctr	San Diego	California	United States	92103
4	Univ of Kansas School of Medicine	Wichita	Kansas	United States	67214
5	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York	United States	117948153
6	Duke Univ Med Ctr	Durham	North Carolina	United States	27710
7	East Carolina Univ School of Medicine	Greenville	North Carolina	United States	278584354
8	Bowman Gray School of Medicine	Winston Salem	North Carolina	United States	271571042
9	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
10	Pennsylvania State Univ / Hershey Med Ctr	Hershey	Pennsylvania	United States	17033
11	Univ TX Galveston Med Branch	Galveston	Texas	United States	775550882