Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179335
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2005-09-10
Brief Title:
Comparative Pharmacokinetics PK Study of Efavirenz or LopinavirRitonavir Between Older and Younger HIV-Infected Adults
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Cross Sectional Case-Sectional Control Pharmacokinetic Study of Efavirenz or LopinavirRitonavir as Part of an Antiretroviral Regimen With Two Nucleosides in HIV-Infected Adults 55 Years of Age or Older Compared With Adults Aged 18-35 Years
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HIV infected patients aged 35 years and aged 55 years who are regularly taking either efavirenz EFV or lopinavirritonavir Lopr as part of their antiretroviral regimen are being asked to spend 12 hours at the researchers clinic the ACS clinic at Jacobi Medical Center Bronx New York for an intensive pharmacokinetic study in which 5 cc of blood will be drawn 9 times over a 12 hour period Patients taking EFV will return for one additional blood draw the following day
Detailed Description:
HIV infected patients aged 35 years and aged 55 years who are regularly taking either efavirenz or lopinavirritonavir as part of their antiretroviral regimen are being asked to spend 12 hours at our clinic the ACS clinic at Jacobi Medical Center Bronx NY for an intensive pharmacokinetic study in which 5 cc of blood will be drawn 9 times over a 12 hour period Patients taking EFV will return for one additional blood draw the following day
Patients will be asked to come to the clinic at 7 am and bring their medication to the clinic Blood will be drawn to obtain a trough level of either EFV or Lopr after which the patient will be instructed to take their EFV or Lopr Then blood will be drawn 1 hour 2 hours 3 hours 4 hours 6 hours 8 hours 10 hours and 12 hours later Patients on EFV will be asked to return the next morning for a 24 hour blood level
The blood will be spun and the plasma frozen at - 70 C The plasma samples labelled with the patients initials and the draw date will be shipped to University of Alabama Department of Pharmacology where the drug levels will be measured
Patients will be recruited from the ACS outpatient clinic They will be identified by their providers
Patients will be asked to come to the clinic at 7 am and bring their medication to the clinic Blood will be drawn to obtain a trough level of either EFV or Lopr after which the patient will be instructed to take their EFV or Lopr Then blood will be drawn 1 hour 2 hours 3 hours 4 hours 6 hours 8 hours 10 hours and 12 hours later Patients on EFV will be asked to return the next morning for a 24 hour blood level
The blood will be spun and the plasma frozen at - 70 C The plasma samples labelled with the patients initials and the draw date will be shipped to University of Alabama Department of Pharmacology where the drug levels will be measured
Patients will be recruited from the ACS outpatient clinic They will be identified by their providers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None