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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002316
• Other study ID #: 131A
• Secondary ID: ALK01-006
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1994
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Lobradimil

• Amphotericin B

Locations

Country	Name	City	State
United States	Case Western Reserve Univ	Cleveland	Ohio
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	East Carolina Univ School of Medicine	Greenville	North Carolina
United States	Pennsylvania State Univ / Hershey Med Ctr	Hershey	Pennsylvania
United States	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	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	Univ of Kansas School of Medicine	Wichita	Kansas
United States	Bowman Gray School of Medicine	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States,