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

June 23, 2005 updated by: Alkermes, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Orange, California, United States, 92668
        • UCI Med Ctr
      • San Diego, California, United States, 92103
        • UCSD Treatment Ctr
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Univ of Kansas School of Medicine
    • New York
      • Stony Brook, New York, United States, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
      • Greenville, North Carolina, United States, 278584354
        • East Carolina Univ School of Medicine
      • Winston Salem, North Carolina, United States, 271571042
        • Bowman Gray School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Univ
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Pennsylvania State Univ / Hershey Med Ctr
    • Texas
      • Galveston, Texas, United States, 775550882
        • Univ TX Galveston Med Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 1994

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131A
  • ALK01-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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