The primary objective of this study is to define the mean, variance, and dose proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of daily dosing with 200mg emtricitabine and 300mg of tenofovir disoproxil fumarate (as Truvada®). With this information, a model will be established to predict adherence rates to TFV-DP using DBS. Forty-eight healthy HIV-uninfected adult participants who are at low risk for HIV infection will be randomized to one of 6 sequences consisting of two directly observed dosing regimens, 33%/67%, 33%/100%, 67%/33%, 67%/100%, 100%/33%, and 100%/67% with each dose regimen lasting approximately 12 weeks, separated by an approximately 12 week washout period. DBS will be collected at regular intervals, including during the washout. The hypothesis of the study is that levels of TFV-DP in DBS will predict adherence rates in the preceding 1-3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
52
Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
University of California San Francisco/San Francisco Department of Public Health
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada
TFV-DP concentrations in DBS respective to dosing regimens of 33%, 67%, 100% of daily dosing.
Time frame: Assessed every 2 weeks during the dosing periods and at steady-state, week 12 for the first dosing period and week 36 for the second dosing period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.