The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis
2 other identifiers
interventional
N/A
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
11 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
December 1, 1994
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (11)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCI Med Ctr
Orange, California, 92668, 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
East Carolina Univ School of Medicine
Greenville, North Carolina, 278584354, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, 271571042, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1994-12