NCT04065347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

3.5 years

First QC Date

August 20, 2019

Last Update Submit

August 26, 2024

Conditions

HIV/AIDSAdherence, Medication

Keywords

AdherenceDried Blood SpotsTenofovir-diphosphateAntiretroviral therapyTenofovir alafenamide

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group 1

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

Device: Digital Pill

Group 2

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

Device: Digital Pill

Interventions

Digital PillDEVICE

Digital Pill over encapsulating tenofovir alafenamide ART

Also known as: etectRx ID-Cap System
Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Coyle RP, Morrow M, Mann SC, Mainella V, Ellis SL, Schwab S, Coppinger C, Barker N, Ellison L, Zheng JH, Al Zuabi S, Alpert PE, Carnes TC, Buffkin DE Jr, Chai PR, Bushman LR, Kiser JJ, MaWhinney S, Brooks KM, Anderson PL, Castillo-Mancilla JR. Tenofovir-Diphosphate and Emtricitabine-Triphosphate Adherence Benchmarks in Dried Blood Spots for Persons With HIV Receiving Tenofovir Alafenamide and Emtricitabine-Based Antiretroviral Therapy (QUANTI-TAF). Clin Infect Dis. 2024 Nov 22;79(5):1233-1241. doi: 10.1093/cid/ciae212.

    PMID: 38636950DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMedication Adherence

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Peter L Anderson, PharmD

    University of Colorado-AMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 22, 2019

Study Start

November 21, 2019

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)