Ignite Creation Date:
2024-05-06 @ 9:21 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02968576
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2016-11-08
Brief Title:
Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
A-TEAM
Brief 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 FTCTDF 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 05 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None