Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
| City: |
|
Chapel Hill |
| State: |
|
North Carolina |
| Zip Code: |
|
27599 |
| Conditions: |
|
Human Immunodeficiency Virus |
| Purpose: |
|
Purpose: To see how growing older changes the amount of HIV drugs in the blood of
HIV-infected men and women. Many changes happen in the investigators bodies as the
investigators get older that may affect the way drugs are carried in the blood, broken down
or removed from the body. This study will look at the amount of drug in the blood and cells
of the immune system for patients taking efavirenz, tenofovir and emtricitabine or
atazanavir boosted with ritonavir, tenofovir and emtricitabine.
Participants: The population will comprise of 56 (6 for intensive PK and 50 for sparse
sampling) HIV-infected adults currently adhering to an antiretroviral regimen containing
efavirenz with tenofovir and emtricitabine and the same number and distribution of
HIV-infected adults currently adhering to an antiretroviral regimen containing atazanavir
boosted with ritonavir with tenofovir and emtricitabine.
Procedures (methods): This study will be completed at the University of North Carolina at
Chapel Hill. There will be four groups of subjects: Efavirenz/tenofovir/emtricitabine Group
A, Efavirenz/tenofovir/emtricitabine Group B, Atazanavir/ritonavir/tenofovir/emtricitabine
Group A, and Atazanavir/ritonavir/tenofovir/emtricitabine Group B.
The initial six subjects (Group A) for intensive PK analysis for each regimen will be
recruited from the the UNC ID Clinic or the Moses Cone Health System Infectious Diseases
Clinic, and will be comprised of non-frail subjects not currently receiving interacting
drugs. If subjects provide informed consent, timed blood samples will be obtained to
determine pharmacokinetic parameters around an observed dose of one of the two study
regimens. A whole blood sample will also be collected and stored for potential drug
metabolizing enzymes and transporters genotyping in the future. Group A subjects will
complete a follow-up visit after their sampling visit.
50 subsequent subjects (Group B) for each regimen will be screened simultaneously, with no
more than 10 subjects enrolled for each regimen in Group B prior to the completion and
analysis of Group A. These subjects will also be recruited from either site. Group B
subjects will have two sampling visits with 1 to 3 blood samples obtained at each visit,
with a stored sample for future genotyping obtained on one of the visits. Samples will be
collected just before the next dose, and 2 hours, between 4 and 6 hrs, and between 10 and 14
hours after a medication dose. These visits may coincide with the subjects' regularly
scheduled visit to the clinic, or be scheduled separately, depending on the preference and
availability of the subject.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- HIV positive patients
- Able to provide written informed consent
- Able to comply with their treatment regimen and study procedures
- Currently receiving either efavirenz/tenofovir/emtricitabine or
atazanavir/ritonavir/tenofovir/emtricitabine as treatment for their HIV infection.
Subjects must have been on the regimen for at least 2 weeks
- All women of reproductive potential must have a negative urine pregnancy test
- If participating in sexual activity that could lead to pregnancy, study participant
must use at least one reliable method of contraception.
Exclusion Criteria:
- Displaying the fraility phenotype (Group A only)
- Receiving an interacting medication
- Having missed >3 doses of study medication in the past 30 days
- Patients who will not likely remain on the study regimen during the course of study
participation.
- Anemia (hemoglobin <10 g/dL)
- Abnormal screening laboratory findings
- Pregnancy
- Breastfeeding
- Any condition that may interfere with follow-up or the ability to take the study
medication appropriately.
|
| NCT ID: |
|
NCT01180075 |
| Primary Contact: |
|
Principal Investigator
Julie B Dumond, PharmD
University of North Carolina, Chapel Hill
Julie B Dumond, PharmD
Phone: 919-966-5017
Email: jdumond@unc.edu
|
| Backup Contact: |
|
Email: heather_prince@med.unc.edu
Heather Prince, PA-C
Phone: 919-843-6848
|
| Location Contact: |
|
Chapel Hill, North Carolina 27599
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|