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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Alkermes
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002316

Purpose

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

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Pharmacokinetics Study
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 NLM:

MedlinePlus related topics: AIDS Meningitis

Drug Information available for: Lobradimil Amphotericin B

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002316

Locations

United States, California
UCI Med Ctr
Orange, California, United States, 92668
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
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
Bowman Gray School of Medicine
Winston Salem, North Carolina, United States, 271571042
East Carolina Univ School of Medicine
Greenville, North Carolina, United States, 278584354
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

More Information

No publications provided

Study ID Numbers:	131A, ALK01-006
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002316 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Meningitis
Drug Therapy, Combination

Antifungal Agents
Acquired Immunodeficiency Syndrome
Amphotericin B

Additional relevant MeSH terms:

Abelcet
Anti-Infective Agents
Communicable Diseases
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Infection
Liposomal amphotericin B
Meningitis
Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal

Meningitis, Cryptococcal
Amebicides
Central Nervous System Fungal Infections
Retroviridae Infections
Amphotericin B
RNA Virus Infections
Meningitis, Fungal
Immune System Diseases
Acquired Immunodeficiency Syndrome
Nervous System Diseases
Central Nervous System Diseases
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on November 27, 2009