Status:
COMPLETED
Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01180075
Start Date
May 1 2010
End Date
August 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599