Status:
COMPLETED
Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV/AIDS
Adherence, Medication
Eligibility:
All Genders
18+ years
Brief Summary
This study is being done to evaluate the relationship between adherence to antiretroviral therapy (ART) and HIV drug concentrations in persons living with HIV (PLWH) that are taking tenofovir alafenam...
Detailed Description
PLWH taking or initiating/re-initiating TAF will be recruited for a 16-week study. Upon entering the study, participants will be trained on the use the digital pill to objectively quantify adherence. ...
Eligibility Criteria
Inclusion
- Females or males with HIV, able to give informed consent and comply with study procedures.
- Currently on (\> 6 months), or planning to initiate/re-initiate TAF.
Exclusion
- For females of childbearing age, active pregnancy or any intent to become pregnant
- Hepatitis C (HCV) infection for which treatment is anticipated within the next 16 weeks after enrollment. Treated HCV with sustained virologic response is allowable if last dose of HCV antivirals was \>12 months prior to enrollment
- Advanced renal (eGFR \<30 mL/min/1.73m\*\*2) or liver (Child-Pugh B or C) disease
- History of extensive bowel surgery, gastric bypass, or gastroparesis
- Concomitant use of any prescription or non-prescription drug known (or with the potential) to significantly influence the PK of TAF (e.g. rifamycins, carbamazepine, phenytoin, St. John's Wort, tipranavir)
Key Trial Info
Start Date :
November 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04065347
Start Date
November 21 2019
End Date
May 16 2023
Last Update
August 27 2024
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045