The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis

Phase 1

Completed

• Conditions: Meningitis, Cryptococcal; HIV 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.

Study Timeline

• Status Verified: 1994-12
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

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

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