Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)

September 19, 2023 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

PLWH who are initiating/re-initiating or have been on TAF for > 6 months.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
A total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort.
Device: Digital Pill
Digital Pill over encapsulating tenofovir alafenamide ART
Other Names:
  • etectRx ID-Cap System
Group 2
A total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort.
Device: Digital Pill
Digital Pill over encapsulating tenofovir alafenamide ART
Other Names:
  • etectRx ID-Cap System

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Peter L Anderson, PharmD, University of Colorado-AMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2019

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-0715
  • 1R01AI145453-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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