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Trial record 73 of 578 for:    meningitis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002316
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
Meningitis, Cryptococcal HIV Infections Drug: Lobradimil Drug: Amphotericin B Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Masking: Double
Primary Purpose: Treatment
Official 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Meningitis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002316

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

Layout table for additonal information Identifier: NCT00002316     History of Changes
Other Study ID Numbers: 131A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 1994

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Antifungal Agents
Acquired Immunodeficiency Syndrome
Amphotericin B

Additional relevant MeSH terms:
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Meningitis, Cryptococcal
Meningitis, Fungal
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Fungal Infections
Central Nervous System Infections
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents