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dc.contributor.authorTim R. Cresseyen_US
dc.contributor.authorOraphan Siriprakaisilen_US
dc.contributor.authorVirat Klinbuayaemen_US
dc.contributor.authorJustice Quame-Amagloen_US
dc.contributor.authorRachel W. Kubiaken_US
dc.contributor.authorPra ornsuda Sukrakanchanaen_US
dc.contributor.authorKanchana Than-in-aten_US
dc.contributor.authorJared Baetenen_US
dc.contributor.authorWasna Sirirungsien_US
dc.contributor.authorRatchada Cresseyen_US
dc.contributor.authorPaul K. Drainen_US
dc.description.abstract© 2017 The Author(s). Background: Tenofovir disoproxil fumarate (TDF) is key component of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) for HIV, but existing tools to monitor drug adherence are often inaccurate. Detection of tenofovir (TFV) in accessible biological samples, such as fingerprick blood, urine or oral fluid samples could be a novel objective measure of recent TDF adherence. To measure TFV concentrations associated with different levels of TDF adherence, we designed a randomized clinical trial to assess the blood, urine and oral fluid concentrations of TFV in adults with perfect, moderate and low drug adherence. Methods/design: A randomized, open-label, clinical pharmacokinetic study of tenofovir in healthy adult volunteers without HIV or Hepatitis B infection in Thailand. Consenting, eligible participants are randomized (1:1:1) among three groups to receive a controlled number of TDF (300 mg) doses in a combination pill with emtricitabine (FTC, 200 mg) for six weeks. Participants in Group 1 receive a single TDF/FTC tablet once daily (Perfect adherence); Group 2 receive a single TDF/FTC tablet 4 times/week (Moderate adherence); and Group 3 receive a single TDF/FTC tablet 2 times/week (Low adherence). Blood, plasma, urine and oral fluid samples are collected for drug measurement during three study phases: (i) initial 6-week treatment phase; (ii) intensive 24-h blood sampling phase after 6 weeks; (iii) 4-week washout phase. Thirty adults with evaluable pharmacokinetic samples (10 per group) will be enrolled [based on ensuring 25% precision in pharmacokinetic parameter estimates]. Pre-dose drug concentrations during the treatment phase will be descriptive and comparisons between groups performed using a Kruskal-Wallis test. A non-compartmental pharmacokinetic analysis will be performed on the intensive sampling data at Week 7 and the time course of TFV washout in the difference biological matrices will be reported based on the detected concentrations following drug cessation. Discussion: The results of this randomized trial will define the target concentration thresholds of TFV in blood, urine and oral fluid that can distinguish between different levels of TDF adherence. Such adherence 'benchmarks' can be applied to real-time drug testing and novel point-of-care tests to identify individuals with poor PrEP or ART adherence. Trial registration:ClinicalTrials.govIdentifier NCT03012607.en_US
dc.titleA randomized clinical pharmacokinetic trial of Tenofovir in blood, plasma and urine in adults with perfect, moderate and low PrEP adherence: The TARGET studyen_US
article.title.sourcetitleBMC Infectious Diseasesen_US
article.volume17en_US Mai Universityen_US School of Public Healthen_US of Liverpoolen_US Hospitalen_US of Washington, Seattleen_US
Appears in Collections:CMUL: Journal Articles

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