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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002316
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1994

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002316 on ClinicalTrials.gov Archive Site
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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

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Meningitis, Cryptococcal
  • HIV Infections
  • Drug: Lobradimil
  • Drug: Amphotericin B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002316
131A, ALK01-006
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Alkermes
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NIH AIDS Clinical Trials Information Service
December 1994

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP