Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population

This study is currently recruiting participants.
Verified April 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Julie Dumond, PharmD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01180075
First received: August 10, 2010
Last updated: April 3, 2014
Last verified: April 2014

August 10, 2010
April 3, 2014
May 2010
July 2014   (final data collection date for primary outcome measure)
Clearance estimates for each drug, adjusted for age and frailty [ Time Frame: From 0, 2, 4-6, and 10-14 hr post-dose blood samples ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01180075 on ClinicalTrials.gov Archive Site
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Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population

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.

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Observational
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

HIV Positive patients on a stable regimen consisting of either efavirenz/tenofovir/emtricitabine or atazanavir boosted with ritonavir/tenofovir/emtricitabine

Human Immunodeficiency Virus
  • Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)
    Patients receiving this drug for clinical care at standard dosages will be enrolled.
    Other Name: Atripla
  • Drug: tenofovir/emtricitabine (TDF/FTC)
    Patients receiving this drug for clinical care at standard dosages will be enrolled.
    Other Name: Truvada
  • Drug: Atazanavir (ATV)
    Patients receiving this drug for clinical care at 300mg with 100mg ritonavir daily will be enrolled.
    Other Name: Reyataz
  • Drug: Ritonavir
    Patients receiving this drug for clinical care at 100mg daily with 300mg atazanavir will be enrolled.
    Other Name: Norvir
  • Procedure: Phlebotomy
    Multiple blood draws will be performed in the study, and vary depending on the group.
  • TDF/FTC/EFV Intensive Sampling-Group A
    Patients receiving TDF/FTC/EFV who undergo intensive pharmacokinetic sampling over 24 hours
    Interventions:
    • Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)
    • Procedure: Phlebotomy
  • TDF/FTC/ATV/r Intensive Sampling Group A
    Patients receiving TDF/FTC/ATV/r who undergo intensive pharmacokinetic sampling over 24 hours
    Interventions:
    • Drug: tenofovir/emtricitabine (TDF/FTC)
    • Drug: Atazanavir (ATV)
    • Drug: Ritonavir
    • Procedure: Phlebotomy
  • 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
    Interventions:
    • Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)
    • Procedure: Phlebotomy
  • 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:
    • Drug: tenofovir/emtricitabine (TDF/FTC)
    • Drug: Atazanavir (ATV)
    • Drug: Ritonavir
    • Procedure: Phlebotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Julie B Dumond, PharmD 919-966-5017 jdumond@unc.edu
Contact: Heather Prince, PA-C 919-843-6848 heather_prince@med.unc.edu
United States
 
NCT01180075
09-2120, 1K23AI093156-01A1
No
Julie Dumond, PharmD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Julie B Dumond, PharmD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP