Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | May 2010 |
| End Date: | July 2014 |
| Contact: | Julie B Dumond, PharmD |
| Email: | jdumond@unc.edu |
| Phone: | 919-966-5017 |
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 body as it ages 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 one or two sampling visits with 1 to 4 blood samples obtained at each
visit, with a stored sample for future genotyping obtained on one of the visits. Samples
will be collected just prior to a dose, at 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.
HIV-infected men and women. Many changes happen in the body as it ages 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 one or two sampling visits with 1 to 4 blood samples obtained at each
visit, with a stored sample for future genotyping obtained on one of the visits. Samples
will be collected just prior to a dose, at 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.
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.
- Any clinically significant surgical alterations of the alimentary track, that in the
opinion of the investigators, alters the absorption pharmacokinetics of the drugs of
interest.
We found this trial at
1
site
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
