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NCT01180075 · ClinicalTrials.gov registry record
Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 85
- Enrollment target
NCT01180075 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 85 participants.
The verdict
NCT01180075 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 85 participants
- Enrollment target
Study 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 r
Interventions
- PROCEDURE Phlebotomy
- DRUG Ritonavir
- DRUG Atazanavir (ATV)
- DRUG tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)
- DRUG tenofovir/emtricitabine (TDF/FTC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01180075
The ClinicalTrials.gov registry entry for NCT01180075 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Phlebotomy is the first listed.
NCT01180075 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01180075 about?
NCT01180075 is a clinical study titled "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 blo...
What is the current status of trial NCT01180075?
This trial is currently completed. The enrollment target is 85 participants. The study started on 2010-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01180075?
The interventions under investigation include: Phlebotomy (PROCEDURE), Ritonavir (DRUG), Atazanavir (ATV) (DRUG), tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV) (DRUG), tenofovir/emtricitabine (TDF/FTC) (DRUG).
Who is sponsoring clinical trial NCT01180075?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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