- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179335
Comparative Pharmacokinetics (PK) Study of Efavirenz or Lopinavir/Ritonavir Between Older and Younger HIV-Infected Adults
Cross Sectional Case-Sectional Control Pharmacokinetic Study of Efavirenz or Lopinavir/Ritonavir 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
HIV infected patients, aged </= 35 years and aged >/= 55 years, who are regularly taking either efavirenz or lopinavir/ritonavir 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 Lop/r after which the patient will be instructed to take their EFV or Lop/r. 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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New York
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Bronx, New York, United States, 10461
- Jacobi Medical Center ACS Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- HIV+
- Taking lopinavir/ritonavir or efavirenz
- Age </= 35 years or >/= 55 years
Exclusion Criteria:
- Concurrent therapy with drugs that alter lopinavir/ritonavir levels.
- Other renal or kidney disease.
- Chronic hepatitis B or C
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth R Jenny-Avital, MD, Jacobi Medical Center, Albert Einstein College of Medicine
- Principal Investigator: Edward Acosta, Pharm D, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCI 03 143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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