Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT01180075 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 85 participants. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01180075 record still lists
NCT01180075 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 85 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which Phlebotomy is the first listed.
NCT01180075 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00842283 · 85 participants
Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target
- NCT02133196 · 85 participants · Phase 2
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
- NCT03823144 · 85 participants · NA
Intravital Microscopy in Human Solid Tumors
- NCT03875638 · 85 participants · Phase 2
Treating Hyperexcitability in AD With Levetiracetam
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia