HIV Infections Clinical Trial
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
NCT number | NCT00002316 |
Other study ID # | 131A |
Secondary ID | ALK01-006 |
Status | Completed |
Phase | Phase 1 |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve Univ | Cleveland | Ohio |
United States | Duke Univ Med Ctr | Durham | North Carolina |
United States | Univ TX Galveston Med Branch | Galveston | Texas |
United States | East Carolina Univ School of Medicine | Greenville | North Carolina |
United States | Pennsylvania State Univ / Hershey Med Ctr | Hershey | Pennsylvania |
United States | Los Angeles County - USC Med Ctr | Los Angeles | California |
United States | UCI Med Ctr | Orange | California |
United States | UCSD Treatment Ctr | San Diego | California |
United States | SUNY / Health Sciences Ctr at Stony Brook | Stony Brook | New York |
United States | Univ of Kansas School of Medicine | Wichita | Kansas |
United States | Bowman Gray School of Medicine | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States,
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