The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
NCT ID: NCT00002316
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Lobradimil
Amphotericin B
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Locations
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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
Univ of Kansas School of Medicine
Wichita, Kansas, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
East Carolina Univ School of Medicine
Greenville, North Carolina, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
Pennsylvania State Univ / Hershey Med Ctr
Hershey, Pennsylvania, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Countries
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Other Identifiers
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ALK01-006
Identifier Type: -
Identifier Source: secondary_id
131A
Identifier Type: -
Identifier Source: org_study_id