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

Primary Purpose

Meningitis, Cryptococcal, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lobradimil
Amphotericin B
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring AIDS-Related Opportunistic Infections, Meningitis, Drug Therapy, Combination, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • UCI Med Ctr
  • UCSD Treatment Ctr
  • Univ of Kansas School of Medicine
  • SUNY / Health Sciences Ctr at Stony Brook
  • Duke Univ Med Ctr
  • East Carolina Univ School of Medicine
  • Bowman Gray School of Medicine
  • Case Western Reserve Univ
  • Pennsylvania State Univ / Hershey Med Ctr
  • Univ TX Galveston Med Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00002316
Brief Title
The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alkermes, Inc.

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Cryptococcal, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Meningitis, Drug Therapy, Combination, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lobradimil
Intervention Type
Drug
Intervention Name(s)
Amphotericin B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
UCSD Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina Univ School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
278584354
Country
United States
Facility Name
Bowman Gray School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
271571042
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pennsylvania State Univ / Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550882
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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