The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
This study has been completed.
Sponsor:
Alkermes
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002316
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1994
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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 1 |
| 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:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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 May 16, 2013