NCT05335590

Brief Summary

This is an observational, 48-week, prospective study of PWH treated with TAF in which the investigators will compare TFV-DP concentrations in DBS in virologically suppressed vs. non-suppressed individuals and evaluate the utility of TFV-DP in DBS to predict future viremia. To accomplish this, the investigators will approach PWH currently taking TAF (which is being prescribed by a primary care physician) and who present to the clinic for regular HIV care and HIV VL assessment. Participants will complete up to 3 visits (at least 2 weeks apart) during the 48-week study follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Longer than P75 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

April 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

April 12, 2022

Last Update Submit

May 4, 2026

Conditions

Hiv

Keywords

HIV/AIDSAdherenceTAFDried Blood Spots

Outcome Measures

Primary Outcomes (2)

  • Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated with odds of HIV viral suppression at all study visits

    HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs \>= 20 copies/mL); reference group lowest adherence category for TFV-DP; adjusted odds ratio calculated using generalized estimated equations; concentration cutoffs established in prior research of healthy volunteers and persons with HIV (PWH)

    48 weeks

  • Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated with odds of HIV viremia at next study visit

    HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs \>= 20 copies/mL); reference group lowest adherence category for TFV-DP; adjusted odds ratio calculated using generalized estimated equations; concentration cutoffs established in prior research of healthy volunteers and persons with HIV (PWH)

    48 weeks

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We propose a 48-week observational study at the University of Colorado Hospital Infectious Diseases Group Practice (UCH-IDGP) in PWH taking TAF. Its goals are to define the association between TFV-DP in DBS and viral suppression and future viremia.

You may qualify if:

  • Females or males with HIV (≥18 years), able to give informed consent and comply with study procedures who are having a blood draw as part of their regular clinical care.
  • Being prescribed TAF-based ART \>= 3 months.

You may not qualify if:

  • \. For females, active pregnancy or intent to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health

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 in EDTA tube

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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 Diseases

Study Officials

  • Peter L Anderson, PharmD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 19, 2022

Study Start

April 25, 2022

Primary Completion

May 4, 2026

Study Completion

May 4, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)