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

This study has been completed.

First Received on November 2, 1999. Last Updated on 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:	Endpoint Classification: Pharmacokinetics Study Masking: Double-Blind 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 NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/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
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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002316 History of Changes
Other Study ID Numbers:	131A, ALK01-006
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Meningitis
Meningitis, Cryptococcal
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 Infections
Central Nervous System Diseases

Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 12, 2012