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Completed

NCT Number: NCT00002316

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

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.

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Key information

Conditions

Meningitis, Cryptococcal AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Central Nervous System Diseases Central Nervous System Fungal Infections Central Nervous System Infections Communicable Diseases Cryptococcosis Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Meningitis Meningitis, Fungal Mycoses Nervous System Diseases Neuroinflammatory Diseases Opportunistic Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Los Angeles County - USC Med Ctr, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lobradimil

Drug

Amphotericin B

Drug

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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