Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-21

Study Completion Date

2023-05-16

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.

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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.

Conditions

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HIV/AIDS Adherence, Medication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

A total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort.

Digital Pill

Intervention Type DEVICE

Digital Pill over encapsulating tenofovir alafenamide ART

Group 2

A total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort.

Digital Pill

Intervention Type DEVICE

Digital Pill over encapsulating tenofovir alafenamide ART

Interventions

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Digital Pill

Digital Pill over encapsulating tenofovir alafenamide ART

Intervention Type DEVICE

Other Intervention Names

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etectRx ID-Cap System

Eligibility Criteria

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Inclusion Criteria

1. Females or males with HIV, able to give informed consent and comply with study procedures.
2. Currently on (\> 6 months), or planning to initiate/re-initiate TAF.

Exclusion Criteria

1. For females of childbearing age, active pregnancy or any intent to become pregnant
2. 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
3. Advanced renal (eGFR \<30 mL/min/1.73m\*\*2) or liver (Child-Pugh B or C) disease
4. History of extensive bowel surgery, gastric bypass, or gastroparesis
5. 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No