Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
2 other identifiers
observational
85
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedDecember 2, 2014
December 1, 2014
4.3 years
August 10, 2010
December 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Clearance estimates for each drug, adjusted for age and frailty
From 0, 2, 4-6, and 10-14 hr post-dose blood samples
Study Arms (4)
TDF/FTC/EFV Intensive Sampling-Group A
Patients receiving TDF/FTC/EFV who undergo intensive pharmacokinetic sampling over 24 hours
TDF/FTC/ATV/r Intensive Sampling Group A
Patients receiving TDF/FTC/ATV/r who undergo intensive pharmacokinetic sampling over 24 hours
TDF/FTC/EFV Sparse Sampling Group B
Patients receiving TDF/FTC/EFV who undergo sparse pharmacokinetic sampling on 1 or 2 visits depending on subject's availability
TDF/FTC/ATV/r Sparse Sampling Group B
Patients receiving TDF/FTC/ATV/r who undergo sparse pharmacokinetic sampling on 1 or 2 visits depending on subject's availability
Interventions
Patients receiving this drug for clinical care at standard dosages will be enrolled.
Patients receiving this drug for clinical care at standard dosages will be enrolled.
Patients receiving this drug for clinical care at 300mg with 100mg ritonavir daily will be enrolled.
Patients receiving this drug for clinical care at 100mg daily with 300mg atazanavir will be enrolled.
Multiple blood draws will be performed in the study, and vary depending on the group.
Eligibility Criteria
HIV Positive patients on a stable regimen consisting of either efavirenz/tenofovir/emtricitabine or atazanavir boosted with ritonavir/tenofovir/emtricitabine
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Dumond JB, Francis O, Cottrell M, Trezza C, Prince HM, Mollan K, Sykes C, Torrice C, White N, Malone S, Wang R, Van Dam C, Patterson KB, Hudgens MG, Sharpless NE, Forrest A. Tenofovir/emtricitabine metabolites and endogenous nucleotide exposures are associated with p16(INK4a) expression in subjects on combination therapy. Antivir Ther. 2016;21(5):441-5. doi: 10.3851/IMP3017. Epub 2016 Jan 5.
PMID: 26731175DERIVED
Biospecimen
Blood samples for determining drug concentrations and for future genetic testing of drug metabolizing enzymes and transporters will be stored for up to 5 years.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie B Dumond, PharmD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 11, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
December 2, 2014
Record last verified: 2014-12