The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: December 1994
History of Changes
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.
Drug : Lobradimil
Drug : Amphotericin B
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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis.
- HIV infection.
- Acute cryptococcal meningitis.
- 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.
- 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.
- 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.
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002316
Locations Show More
|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 CollaboratorsAlkermes, Inc.
|Responsible Party:||Alkermes, Inc.|
|ClinicalTrials.gov Identifier:||NCT00002316 History of Changes|
|Other Study ID Numbers:||131A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Liposomal amphotericin B
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.