Dose-Proportionality and Intra-Individual Variability of Intracellular TFV-DP and FTC-TP in Healthy Volunteers



Status:Archived
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:January 2011
End Date:June 2012

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Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate In Healthy Volunteers


Describe the dose-proportionality and intra-individual variability of tenofovir diphosphate
(TFV-DP) and emtricitabine triphosphate (FTC-TP) at steady-state in healthy human
participants taking Truvada® (FTC 200mg/TDF 300 mg) under direct observation.


This PK study is designed to establish the dose-proportionality of TFV and FTC (serum and
intracellular forms) with daily to weekly dosing. This information is essential to (1)
employ drug concentration as an adherence measure in future PrEP studies, and (2) to
estimate the anticipated concentration of parent and active moieties of TFV and FTC in
intermittent PrEP regimens associated with full adherence to a prescribed regimen. In
addition, intra-individual variability will be assessed to improve sample size estimates in
future PrEP studies that use drug concentration as an adherence measure or where PK-PD
correlations are planned. The dose-proportionality of intra-cellular phosphates of the two
components of the study product has not previously been established. Given the complexity of
movement of these drugs between body compartments (central compartment, vaginal mucosal
tissue, vaginal lumen, gastrointestinal mucosal tissue, gastrointestinal lumen), into cells
within these compartments, and intra-cellular phosphorylation, it is possible that non-dose
proportional kinetics, such as mixed or zero-order saturable processes may be operating.


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101 Manning Dr
Chapel Hill, North Carolina 27599
(919) 966-4131
University of North Carolina Hospital at Chapel Hill The UNC Health Care System is a...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
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