Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)

Completed

• Conditions: Adherence, Medication; HIV/AIDS
• Interventions: Device: Digital Pill

• Registration Number: NCT04065347
• Lead Sponsor: University of Colorado, Denver

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 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

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.

Study Timeline

• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-22
• Study Start: 2019-11-21
• Primary Completion: 2023-05-16
• Study Completion: 2023-05-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Digital Pill	A total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort.
Group 1	Digital Pill	A total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort.

Primary Outcome Measures

Name	Time	Method
Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)	Week 16	Steady-state drug concentration distribution and quantiles for highly adherent (i.e. \>95% of ingestions) participants.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States