Healthy VolunteersPhase 1TAF-DBSNCT02962739

The Cellular Pharmacology of F-TAF in Dried Blood Spots

A Phase 1 study testing emtricitabine 200 mg/tenofovir alafenamide 25mg in people with Healthy Volunteers, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: emtricitabine 200 mg/tenofovir alafenamide 25mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: Mar 2016to 22 May 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Ambulatory 18-59 year old adults. Enrollment will proceed without the need to meet specific race/gender targets, but balanced gender and African-Americans and Latino representation will be sought.
Ability to comply with study procedures, including directly observed dosing visits and availability and use of video streaming technology.

Who cannot join

Inability to give informed consent
Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
Current breastfeeding
High risk of HIV-1 infection, for example:
sexually active with an HIV infected partner;
men who have sex with men who may engage in condomless intercourse with HIVinfected partners, or

Show all 37Show fewer

partner of unknown status during the study;
males or females who exchange sex for money, shelter, or gifts;
active injection drug use or during the last 12 months;
newly diagnosed sexually transmitted infections in last 6 months
Positive screening HIV+ ELISA or suspected acute HIV infection in the opinion of the clinician. Example signs and symptoms of acute HIV infection include combinations of:
fever,
headache,
fatigue,
arthralgia,
vomiting,
myalgia, .
diarrhea,
pharyngitis,
rash,
night sweats, and
adenopathy (cervical or inguinal)
Positive Hepatitis B Virus (HBV) surface antigen test at screening
Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
Glomerular Filtration Rate (GFR) estimate < 60 ml/min (MDRD equation).
Urine dipstick protein ≥ 2+
Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
Symptomatic hemoglobinopathies or active hemolysis.
History of pathological, non-traumatic bone fractures
Any laboratory value or uncontrolled medical conditions that, in the opinion of the investigators, would interfere with the study conditions such as, heart disease and/or cancer.
Prohibited concomitant medications are:
investigational agents (within 30 days of enrollment),
aminoglycosides,
ganciclovir/valganciclovir,
chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for 7 days),
cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TRUVADA®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado- Anschutz Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide (F/TAF) works for treatment of chronic human immunodeficiency virus (HIV), or prevention of HIV acquisition. Methods to measure medication adherence to Tenofovir disoproxil fumarate (tenofovir DF, TDF), a similar but different prodrug of tenofovir, have been developed but cannot be extrapolated to F-TAF. By measuring F-TAF (the drug) and metabolites in the blood cells and dried blood spots, the study plans to see if these results predict adherence to taking the drug. The goal of this study is to vary the amount of F-TAF dosing and see if the drug levels in dried blood spots (DBS) change in a predictable way. This study will mimic different levels of adherence (33%, 67%, and 100% of daily dosing) using directly observed therapy (DOT) to establish the relationship between F-TAF in dried blood spots and adherence. Investigators will also measure drug in hair clippings to see if hair or DBS are a better predictor of adherence.

Conditions: Healthy Volunteers
Being tested: emtricitabine 200 mg/tenofovir alafenamide 25mg
Keywords: healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

emtricitabine 200 mg/tenofovir alafenamide 25mgDrug
Also called Descovy
1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg

Study groups in NCT02962739
Study group	Role	What they receive
33%/67% dosing	Active comparator	The 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). Receives: Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
33%/100% dosing	Active comparator	The 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses. Receives: Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
67%/33% dosing	Active comparator	The 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). Receives: Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
67%/100% dosing	Active comparator	67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses. Receives: Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
100%/33% dosing	Active comparator	The 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses. Receives: Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
100%/67% dosing	Active comparator	67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses. Receives: Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing.
Measured: Assessed weekly for 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201622 May 2019

First posted11 Nov 2016 (estimated)
Study startMar 2016
Primary completion22 May 2019
Study completion22 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies 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: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02962739
Sponsor's protocol ID: 16-0972
Acronym: TAF-DBS
Status last verified: Jan 2021
First submitted: 8 Nov 2016
Last updated: 25 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Yager J, Castillo-Mancilla J, Ibrahim ME, Brooks KM, McHugh C, Morrow M, McCallister S, Bushman LR, MaWhinney S, Kiser JJ, Anderson PL. Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots Following Tenofovir Alafenamide: The TAF-DBS Study. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):323-330. doi: 10.1097/QAI.0000000000002354.
PubMed 32539288

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Cellular Pharmacology of F-TAF in Dried Blood Spots
ClinicalTrials.gov ID: NCT02962739
Acronym / sponsor ID: TAF-DBS / 16-0972
Conditions: Healthy Volunteers
Keywords: healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: 22 May 2019 (actual)
Study completion: 22 May 2019 (actual)
First posted: 11 Nov 2016 (estimated)
Results: Posted 25 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
33%/67% dosing	Active comparator	Drug: emtricitabine 200 mg/tenofovir alafenamide 25mgThe 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks).
33%/100% dosing	Active comparator	Drug: emtricitabine 200 mg/tenofovir alafenamide 25mgThe 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses.
67%/33% dosing	Active comparator	Drug: emtricitabine 200 mg/tenofovir alafenamide 25mgThe 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks).
67%/100% dosing	Active comparator	Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses.
100%/33% dosing	Active comparator	Drug: emtricitabine 200 mg/tenofovir alafenamide 25mgThe 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses.
100%/67% dosing	Active comparator	Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Ambulatory 18-59 year old adults. Enrollment will proceed without the need to meet specific race/gender targets, but balanced gender and African-Americans and Latino representation will be sought.
Ability to comply with study procedures, including directly observed dosing visits and availability and use of video streaming technology.

Key exclusion criteria (37 listed)

Inability to give informed consent
Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
Current breastfeeding
High risk of HIV-1 infection, for example:
Positive screening HIV+ ELISA or suspected acute HIV infection in the opinion of the clinician. Example signs and symptoms of acute HIV infection include combinations of:

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
emtricitabine 200 mg/tenofovir alafenamide 25mgAlso: Descovy1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg	Drug	100%/33% dosing, 100%/67% dosing, 33%/100% dosing, 33%/67% dosing, 67%/100% dosing, 67%/33% dosing

Primary outcome

Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy
Time frame: Assessed weekly for 9 months
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing.

Results and safety

Results posted to the registry on 25 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

The registry did not answer just now, so the posted figures can't be shown here. Open the results on ClinicalTrials.gov.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32539288Yager J, Castillo-Mancilla J, Ibrahim ME, Brooks KM, McHugh C, Morrow M, McCallister S, Bushman LR, MaWhinney S, Kiser JJ, Anderson PL. Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots Following Tenofovir Alafenamide: The TAF-DBS Study. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):323-330. doi: 10.1097/QAI.0000000000002354.
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 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?

A Phase 1 study testing emtricitabine 200 mg/tenofovir alafenamide 25mg in people with Healthy Volunteers, 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 37 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 25 Jan 2021. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy (time frame: Assessed weekly for 9 months). 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 NCT02962739, 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 25 Jan 2021.