Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
Poor adherence to tenofovir (TDF) and emtricitabine (FTC) for Human Immunodeficiency Virus
(HIV) pre-exposure prophylaxis (PrEP) is common and the leading cause of therapeutic failure.
The investigators need better ways to measure adherence in patients on PrEP. This application
will address the need to measure adherence by evaluating an integrated technology system,
Proteus Discover, when combined with Truvada. The Proteus Sensor System (PSS) will confirm
that Truvada was taken, monitor adherence in both recent and long term dosing, and provides
feedback to encourage adherence. The goal of this study is to determine whether the use of
the PSS with Truvada will vary the drug concentrations of FTC/TDF. Participants will have 2
study visits where they will be randomized to either start with the combined PSS with Truvada
or just Truvada alone. Study participants will come to the Clinical & Translational Research
Center (CTRC) in the morning and take the assigned dose and will then have blood drawn at
about .25, 0.5, 1, 2, 4, 6, and 10 hours after medication is taken. Participants will then
return to the CTRC for blood draws 24, 48, and 72 hours after they took the dose on the first
day. The second visit will mimic the first except that the participant will take the other
dose form.
Phase:
N/A
Details
Lead Sponsor:
University of Colorado, Denver
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir