Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
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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.
| Condition | Intervention |
|---|---|
|
Human Immunodeficiency Virus |
Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV) Drug: tenofovir/emtricitabine (TDF/FTC) Drug: Atazanavir (ATV) Drug: Ritonavir Procedure: Phlebotomy |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population |
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.
| Estimated Enrollment: | 112 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
TDF/FTC/EFV Intensive Sampling-Group A
Patients receiving TDF/FTC/EFV who undergo intensive pharmacokinetic sampling over 24 hours
|
Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)
Patients receiving this drug for clinical care at standard dosages will be enrolled.
Other Name: Atripla
Procedure: Phlebotomy
Multiple blood draws will be performed in the study, and vary depending on the group.
|
|
TDF/FTC/ATV/r Intensive Sampling Group A
Patients receiving TDF/FTC/ATV/r who undergo intensive pharmacokinetic sampling over 24 hours
|
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 Sparse Sampling Group B
Patients receiving TDF/FTC/EFV who undergo sparse pharmacokinetic sampling on 2 occasions
|
Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)
Patients receiving this drug for clinical care at standard dosages will be enrolled.
Other Name: Atripla
Procedure: Phlebotomy
Multiple blood draws will be performed in the study, and vary depending on the group.
|
|
TDF/FTC/ATV/r Sparse Sampling Group B
Patients receiving TDF/FTC/ATV/r who undergo sparse pharmacokinetic sampling on 2 occasions
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
HIV Positive patients on a stable regimen consisting of either efavirenz/tenofovir/emtricitabine or atazanavir boosted with ritonavir/tenofovir/emtricitabine
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.
Contacts and Locations| 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, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: Julie B Dumond, PharmD | |
| Principal Investigator: | Julie B Dumond, PharmD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | Julie Dumond, Research Assistant Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01180075 History of Changes |
| Other Study ID Numbers: | 09-2120, 1K23AI093156-01A1 |
| Study First Received: | August 10, 2010 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Ritonavir Atazanavir Tenofovir Tenofovir disoproxil |
Efavirenz Emtricitabine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2013
