Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex
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The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7 days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of patients with disseminated cryptococcosis and HIV.
Condition | Intervention | Phase |
---|---|---|
Invasive Cryptococcosis |
Drug: ABLC |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex at 10 mg/kg/d for 7 Days or 5.0 mg/kg/d for 14 Days as Induction Therapy for Disseminated Cryptococcosis in Patients With HIV |
- Survival [ Designated as safety issue: No ]
- Time to Sterilization of CSF [ Designated as safety issue: No ]
- Infusion related and renal toxicity [ Designated as safety issue: Yes ]
Estimated Enrollment: | 18 |
Study Start Date: | January 2007 |
Study Completion Date: | January 2010 |
Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 5 mg/kg/d ABLC x 14 days
5 mg/kg/d of Amphotericin B Lipid Complex for 14 days
|
Drug: ABLC |
Experimental: 10/kg/kg/d x 7 days
10 mg/kg/d of Amphotericin B Lipid Complex for 7 days
|
Drug: ABLC |
Detailed Description:
This is a randomized, open label, prospective study of ABLC at 5.0 and 10.0 mg/kg/d for treatment of patients with cryptococcal meningitis. Patients will be randomly assigned in a 1:1 ratio to receive 5.0 or 10.0 mg/kg/d of ABLC as induction therapy for cryptococcal meningitis. Patients receiving 10 mg/kg/d doses will be treated with ABLC for 7 days whereas patients receiving ABLC at 5.0 mg/kg/d will receive 14 days of ABLC therapy. After completion of induction therapy subjects will receive long-term fluconazole maintenance therapy at the discretion of the treating physician. The study will be conducted at the Washington Hospital Center
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of cryptococcal meningitis based on any of the following:
- Cerebrospinal fluid positive for C. neoformans
- Cerebrospinal fluid positive for cryptococcal antigen
- Male or female 18 years of age or older.
- All female patients must be non-lactating and have a negative serum pregnancy test at time of screening. Females of childbearing potential must be using a medically acceptable method of contraception and agree to continue its use during the study period, or must be one year postmenopausal, or have been surgically sterilized.
- Willing and able to give a signed informed consent, or have a legally authorized representative who is willing or able to give consent
Exclusion Criteria:
- A history or evidence of hypersensitivity to AmB or any of its metabolites.
- A history or evidence of any psychiatric, neurological metabolic, or other chronic condition, which in the investigator's opinion, would make the patient unsuitable for the study or interfere with the evaluation of ABLC.
- Inability to comply with the procedures of the study.
- Patients who have received greater than 72 hours of therapy with another systemic antifungal agent within 2 weeks prior to enrollment
Patients with any of the following abnormal laboratory values
- Baseline creatinine clearance of less than 50.
- Bilirubin of greater than 5 times the upper limit of normal
- AST or ALT of greater than 10 times the upper limit of normal
- Life expectancy of less than 72 hours
![](https://webarchive.library.unt.edu/web/20130312224352im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, District of Columbia | |
Washington Hospital Center | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Shmuel Shoham, MD | Washington Hospital Center |
![](https://webarchive.library.unt.edu/web/20130312224352im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Medstar Research Institute |
ClinicalTrials.gov Identifier: | NCT01656382 History of Changes |
Other Study ID Numbers: | 2006-273 |
Study First Received: | April 24, 2007 |
Last Updated: | August 2, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medstar Research Institute:
ABLC cryptococcosis |
Additional relevant MeSH terms:
Cryptococcosis Mycoses 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 March 10, 2013