At a glance
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Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor for Determining Adherence Using Different Dosing Regimens of Disoproxil Fumarate/Emtricitabine (TDF/FTC)
In Brief
A Early Phase 1 clinical trial evaluating Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) for HIV/AIDS and 2 related conditions. Completed, enrolled 14 participants across 1 site.
Detailed Summary
Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed to high HIV risk through vaginal acquisition. Adherence to the one pill per day regimen is crucial for its effectiveness in reducing the risk of acquiring HIV. Currently, there is no available point of care diagnostic test to quickly measure blood levels of tenofovir in the clinic. This study will determine whether a tenofovir (TFV) aptamer-based biosensor (aptasensor) can detect TFV in biological fluids from women randomized to different dosing regimens representing high and low adherence.
Study Details
Timeline
Interventions
Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned