Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)

Study Overview
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Brief Summary
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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 alafenamide (TAF). Adherence will be measured with an ingestible biosensor (digital pill). Antiretroviral drug concentrations will be measured in different types of blood cells.

Detailed Description
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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. Study participants already taking TAF will return every 4 weeks for a study visit where blood for drug concentrations will be obtained. Participants initiating/re-initiating TAF will return weekly for the first 4 weeks, at weeks 6 and 8, and every 4 weeks thereafter for a study visit where drug concentrations will be obtained.

Official Title
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Quantification of Tenofovir Alafenamide Adherence and Exposure in Adults Living With HIV

Conditions
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HIV/AIDS, Adherence, Medication

Intervention / Treatment
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* Device: Digital Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>A total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort. | Device: Digital Pill<br>* Digital Pill over encapsulating tenofovir alafenamide ART<br>* Other names: etectRx ID-Cap System;|
| Group 2<br>A total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort. | Device: Digital Pill<br>* Digital Pill over encapsulating tenofovir alafenamide ART<br>* Other names: etectRx ID-Cap System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) | Steady-state drug concentration distribution and quantiles for highly adherent (i.e. >95% of ingestions) participants. | Week 12 | 
| Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) | Steady-state drug concentration distribution and quantiles for highly adherent (i.e. >95% of ingestions) participants. | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Dried Blood Spots, Tenofovir-diphosphate, Antiretroviral therapy, Tenofovir alafenamide