Human Immunodeficiency VirusNCT01180075
Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
An observational study of Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV), tenofovir/emtricitabine (TDF/FTC) and Atazanavir (ATV)
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV Positive patients on a stable regimen consisting of either efavirenz/tenofovir/emtricitabine or atazanavir boosted with ritonavir/tenofovir/emtricitabine
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
Read more
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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV), tenofovir/emtricitabine (TDF/FTC), Atazanavir (ATV), Ritonavir, Phlebotomy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)Drug
Also called Atripla
Patients receiving this drug for clinical care at standard dosages will be enrolled.
tenofovir/emtricitabine (TDF/FTC)Drug
Also called Truvada
Patients receiving this drug for clinical care at standard dosages will be enrolled.
Atazanavir (ATV)Drug
Also called Reyataz
Patients receiving this drug for clinical care at 300mg with 100mg ritonavir daily will be enrolled.
RitonavirDrug
Also called Norvir
Patients receiving this drug for clinical care at 100mg daily with 300mg atazanavir will be enrolled.
PhlebotomyProcedure or surgery
Multiple blood draws will be performed in the study, and vary depending on the group.
| Study group | Role | What they receive |
|---|---|---|
| TDF/FTC/EFV Intensive Sampling-Group A | Patients receiving TDF/FTC/EFV who undergo intensive pharmacokinetic sampling over 24 hours Receives: 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 Receives: 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 Receives: 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 Receives: Drug: tenofovir/emtricitabine (TDF/FTC); Drug: Atazanavir (ATV); Drug: Ritonavir; Procedure: Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance estimates for each drug, adjusted for age and frailty
Measured: From 0, 2, 4-6, and 10-14 hr post-dose blood samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Dumond, PharmD, University of North Carolina, Chapel Hill
- Investigators
- Julie B Dumond, PharmD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180075
- Sponsor's protocol ID
- 09-2120
- Other IDs
- 1K23AI093156-01A1
- Status last verified
- Dec 2014
- First submitted
- 10 Aug 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26731175
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
- ClinicalTrials.gov ID
- NCT01180075
- Acronym / sponsor ID
- 09-2120
- Conditions
- Human Immunodeficiency Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TDF/FTC/EFV Intensive Sampling-Group A | – | Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV), Procedure: PhlebotomyPatients receiving TDF/FTC/EFV who undergo intensive pharmacokinetic sampling over 24 hours |
| TDF/FTC/ATV/r Intensive Sampling Group A | – | Drug: tenofovir/emtricitabine (TDF/FTC), Drug: Atazanavir (ATV), Drug: Ritonavir, Procedure: PhlebotomyPatients receiving TDF/FTC/ATV/r who undergo intensive pharmacokinetic sampling over 24 hours |
| TDF/FTC/EFV Sparse Sampling Group B | – | Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV), Procedure: PhlebotomyPatients 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 | – | Drug: tenofovir/emtricitabine (TDF/FTC), Drug: Atazanavir (ATV), Drug: Ritonavir, Procedure: PhlebotomyPatients receiving TDF/FTC/ATV/r who undergo sparse pharmacokinetic sampling on 1 or 2 visits depending on subject's availability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV Positive patients on a stable regimen consisting of either efavirenz/tenofovir/emtricitabine or atazanavir boosted with ritonavir/tenofovir/emtricitabine
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)Also: AtriplaPatients receiving this drug for clinical care at standard dosages will be enrolled. | Drug | TDF/FTC/EFV Intensive Sampling-Group A, TDF/FTC/EFV Sparse Sampling Group B |
| tenofovir/emtricitabine (TDF/FTC)Also: TruvadaPatients receiving this drug for clinical care at standard dosages will be enrolled. | Drug | TDF/FTC/ATV/r Intensive Sampling Group A, TDF/FTC/ATV/r Sparse Sampling Group B |
| Atazanavir (ATV)Also: ReyatazPatients receiving this drug for clinical care at 300mg with 100mg ritonavir daily will be enrolled. | Drug | TDF/FTC/ATV/r Intensive Sampling Group A, TDF/FTC/ATV/r Sparse Sampling Group B |
| RitonavirAlso: NorvirPatients receiving this drug for clinical care at 100mg daily with 300mg atazanavir will be enrolled. | Drug | TDF/FTC/ATV/r Intensive Sampling Group A, TDF/FTC/ATV/r Sparse Sampling Group B |
| PhlebotomyMultiple blood draws will be performed in the study, and vary depending on the group. | Procedure or surgery | TDF/FTC/ATV/r Intensive Sampling Group A, TDF/FTC/ATV/r Sparse Sampling Group B, TDF/FTC/EFV Intensive Sampling-Group A, TDF/FTC/EFV Sparse Sampling Group B |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 26731175Dumond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie B Dumond, PharmD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.