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The Cellular Pharmacology of F-TAF in Dried Blood Spots (TAF-DBS)

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ClinicalTrials.gov Identifier: NCT02962739
Recruitment Status : Completed
First Posted : November 11, 2016
Results First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Cellular Pharmacology of F-TAF in Dried Blood Spots
Actual Study Start Date : March 2016
Actual Primary Completion Date : May 22, 2019
Actual Study Completion Date : May 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Active Comparator: 33%/67% dosing
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).
Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
Other Name: Descovy

Active Comparator: 33%/100% dosing
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.
Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
Other Name: Descovy

Active Comparator: 67%/33% dosing
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).
Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
Other Name: Descovy

Active Comparator: 67%/100% dosing
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.
Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
Other Name: Descovy

Active Comparator: 100%/33% dosing
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.
Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
Other Name: Descovy

Active Comparator: 100%/67% dosing
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.
Drug: emtricitabine 200 mg/tenofovir alafenamide 25mg
1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
Other Name: Descovy




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Ability to comply with study procedures, including directly observed dosing visits and availability and use of video streaming technology.

Exclusion Criteria:

  1. Inability to give informed consent
  2. Pregnancy or plan to become pregnant in the next 12 months or unwillingness to use birth control
  3. Current breastfeeding
  4. 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
    • 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
  5. 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)
  6. Positive Hepatitis B Virus (HBV) surface antigen test at screening
  7. Active psychiatric illness, social condition, or alcohol/drug abuse that, in the opinion of the investigators, would interfere with study requirements.
  8. Glomerular Filtration Rate (GFR) estimate < 60 ml/min (MDRD equation).
  9. Urine dipstick protein ≥ 2+
  10. Total bilirubin and/or hepatic transaminases (ALT and AST) ≥ 2.5x upper limit of normal
  11. Absolute neutrophil count ≤ 1,500/mm3, platelets count ≤ 100,000/mm3, or hemoglobin ≤ 10 g/dL.
  12. Symptomatic hemoglobinopathies or active hemolysis.
  13. History of pathological, non-traumatic bone fractures
  14. 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.
  15. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962739


Locations
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United States, Colorado
University of Colorado- Anschutz Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Peter Anderson, PharmD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Publications of Results:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02962739    
Other Study ID Numbers: 16-0972
First Posted: November 11, 2016    Key Record Dates
Results First Posted: January 25, 2021
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
healthy volunteers
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents