HIV/AIDSNCT04065347
Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)
An observational study of HIV/AIDS and Adherence, Medication, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Adherence, Medication
- What is being tested?
- Digital Pill
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to 16 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PLWH who are initiating/re-initiating or have been on TAF for > 6 months.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Digital Pill
- Keywords
- Adherence, Dried Blood Spots, Tenofovir-diphosphate, Antiretroviral therapy, Tenofovir alafenamide
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital PillDevice
Also called etectRx ID-Cap System
Digital Pill over encapsulating tenofovir alafenamide ART
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | A total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort. Receives: Device: Digital Pill | |
| Group 2 | A total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort. Receives: Device: Digital Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start21 Nov 2019
- Primary completion16 May 2023
- Study completion16 May 2023
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 HIV/AIDSStudies 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
- 84 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-AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065347
- Sponsor's protocol ID
- 19-0715
- Other IDs
- 1R01AI145453-01A1
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2019
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Tenofovir Alafenamide Adherence and Exposure in Adults Living With HIV
- ClinicalTrials.gov ID
- NCT04065347
- Acronym / sponsor ID
- 19-0715
- Conditions
- HIV/AIDS, Adherence, Medication
- Keywords
- Adherence, Dried Blood Spots, Tenofovir-diphosphate, Antiretroviral therapy, Tenofovir alafenamide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 22 Aug 2019 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Digital PillA total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort. |
| Group 2 | – | Device: Digital PillA total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PLWH who are initiating/re-initiating or have been on TAF for > 6 months.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital PillAlso: etectRx ID-Cap SystemDigital Pill over encapsulating tenofovir alafenamide ART | Device | Group 1, Group 2 |
Primary outcome
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.
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.
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 27 Aug 2024.
- 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
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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-AMC
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/AIDS and Adherence, Medication, 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 5 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 27 Aug 2024. 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?
Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) (time frame: Week 12). 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 NCT04065347, 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 27 Aug 2024.