HivACTNCT05335590
Adherence and Clinical Correlates in Persons With HIV on TAF
An observational study of Hiv, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hiv
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 4 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. For females, active pregnancy or intent to become pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
Antiretroviral (ARV) drug exposure is directly linked to individual host factors, including age, weight, diet, and genetics. However, the main factor influencing long-term drug exposure is drug adherence. Adherence is a strong predictor of HIV treatment outcomes, but measuring adherence is difficult due to the inaccuracy of self-reporting and other commonly used monitoring methods. There is no gold-standard measure to monitor ARV exposure and adherence that has been implemented in clinical practice. Tenofovir diphosphate (TFV-DP), the phosphorylated anabolite of tenofovir (TFV), has distinct pharmacological characteristics that make it an ideal candidate for drug adherence and exposure monitoring. The long half-life of TFV-DP (~17 days) in red blood cells (RBC), which are abundant in dried blood spots (DBS) are properties that make it well suited for monitoring average TFV exposure over time both from tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). TFV-DP in DBS in persons with HIV (PWH) on TDF has been associated with viral suppression and is predictive of future viremia, even in patient who are virologically-suppressed. However, data on TFV-DP in DBS from TAF are lacking. To address this gap, this study will assess the association of TFV-DP in DBS from PWH on TAF with clinically-relevant virologic outcomes.
- Conditions
- Hiv
- Keywords
- HIV/AIDS, Adherence, TAF, Dried Blood Spots
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start25 Apr 2022
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter L Anderson, PharmD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335590
- Sponsor's protocol ID
- 22-0422
- Acronym
- ACT
- Status last verified
- May 2026
- First submitted
- 12 Apr 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38636950
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and Clinical Correlates in Persons With HIV on TAF
- ClinicalTrials.gov ID
- NCT05335590
- Acronym / sponsor ID
- ACT / 22-0422
- Conditions
- Hiv
- Keywords
- HIV/AIDS, Adherence, TAF, Dried Blood Spots
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Antiretroviral (ARV) drug exposure is directly linked to individual host factors, including age, weight, diet, and genetics. However, the main factor influencing long-term drug exposure is drug adherence. Adherence is a strong predictor of HIV treatment outcomes, but measuring adherence is difficult due to the inaccuracy of self-reporting and other commonly used monitoring methods. There is no gold-standard measure to monitor ARV exposure and adherence that has been implemented in clinical practice. Tenofovir diphosphate (TFV-DP), the phosphorylated anabolite of tenofovir (TFV), has distinct pharmacological characteristics that make it an ideal candidate for drug adherence and exposure monitoring. The long half-life of TFV-DP (~17 days) in red blood cells (RBC), which are abundant in dried blood spots (DBS) are properties that make it well suited for monitoring average TFV exposure over time both from tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). TFV-DP in DBS in persons with HIV (PWH) on TDF has been associated with viral suppression and is predictive of future viremia, even in patient who are virologically-suppressed. However, data on TFV-DP in DBS from TAF are lacking. To address this gap, this study will assess the association of TFV-DP in DBS from PWH on TAF with clinically-relevant virologic outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. For females, active pregnancy or intent to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 48 weeks
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)
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
Time frame: 48 weeks
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 38636950Coyle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter L Anderson, PharmD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.