NCT04065347

Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV/AIDS
• Adherence, Medication

Interventions

Type	Name	Description
DEVICE	Digital Pill	Digital Pill over encapsulating tenofovir alafenamide ART

Timeline

• Start date: 2019-11-21
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2019-08-22
• Last updated: 2024-08-27

Locations

1 site across 1 country: United States