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.

Condition	Treatment or Intervention	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Lobradimil  Drug: Amphotericin B	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

California
      UCI Med Ctr, Orange,  California,  92668,  United States
      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States
      UCSD Treatment Ctr, San Diego,  California,  92103,  United States
Kansas
      Univ of Kansas School of Medicine, Wichita,  Kansas,  67214,  United States
New York
      SUNY / Health Sciences Ctr at Stony Brook, Stony Brook,  New York,  117948153,  United States
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
      Bowman Gray School of Medicine, Winston Salem,  North Carolina,  271571042,  United States
      East Carolina Univ School of Medicine, Greenville,  North Carolina,  278584354,  United States
Ohio
      Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States
Pennsylvania
      Pennsylvania State Univ / Hershey Med Ctr, Hershey,  Pennsylvania,  17033,  United States
Texas
      Univ TX Galveston Med Branch, Galveston,  Texas,  775550882,  United States

Study ID Numbers:  131A; ALK01-006
Record last reviewed:  December 1994
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002316
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08