The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningitis, Cryptococcal; HIV Infections
Intervention: Lobradimil (Drug); Amphotericin B (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Alkermes
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.
Clinical Details
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 design: Treatment, Double-Blind, Pharmacokinetics Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
UCI Med Ctr, Orange, California 92668, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
UCSD Treatment Ctr, San Diego, California 92103, United States
Univ of Kansas School of Medicine, Wichita, Kansas 67214, United States
SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York 117948153, United States
Duke Univ Med Ctr, Durham, North Carolina 27710, United States
Bowman Gray School of Medicine, Winston Salem, North Carolina 271571042, United States
East Carolina Univ School of Medicine, Greenville, North Carolina 278584354, United States
Case Western Reserve Univ, Cleveland, Ohio 44106, United States
Pennsylvania State Univ / Hershey Med Ctr, Hershey, Pennsylvania 17033, United States
Univ TX Galveston Med Branch, Galveston, Texas 775550882, United States
Additional Information
Last updated: June 23, 2005
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