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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002316
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Meningitis, Cryptococcal

Keywords

AIDS-Related Opportunistic Infections, Meningitis, Drug Therapy, Combination, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B

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.

Interventions

DRUGLobradimil
DRUGAmphotericin B

Sponsors

Alkermes, Inc.
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026