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.
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
Purpose
TREATMENT
Masking
DOUBLE
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
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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
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