The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
- Conditions
- Meningitis, CryptococcalHIV Infections
- Registration Number
- NCT00002316
- Lead Sponsor
- Alkermes, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
SUNY / Health Sciences Ctr at Stony Brook
🇺🇸Stony Brook, New York, United States
Pennsylvania State Univ / Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
UCSD Treatment Ctr
🇺🇸San Diego, California, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Bowman Gray School of Medicine
🇺🇸Winston Salem, North Carolina, United States
East Carolina Univ School of Medicine
🇺🇸Greenville, North Carolina, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
UCI Med Ctr
🇺🇸Orange, California, United States