Tenofovir Adherence to Rapidly Guide and Evaluate PrEP and HIV Therapy
Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
Adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are critical to
the success of HIV treatment and therapeutic prevention. No accurate, objective point-of-care
test is available to monitor adherence to either ART or PrEP. The inability to accurately
identify poorly adherent patients will lead to more HIV infections (from failed PrEP and
non-suppressive ART), more drug-resistant virus (selected by failing ART), and unnecessary
switching to costly second- or third-line ART (when first-line regimens with virologic
efficacy but non-adherence are stopped inappropriately). To address this critical knowledge
gap, the investigators have developed a novel point-of-care test to detect the presence of
tenofovir-the most common drug in both ART and PrEP treatments worldwide-in fingerprick blood
or urine as an objective measure of ART and PrEP adherence.
Our central hypothesis is that the pharmacokinetics of tenofovir in blood and urine will
support point-of-care tenofovir detection as an objective measure of adherence, and that our
point-of-care tenofovir assay will have the ability to discriminate different drug adherence
levels. The investigators will test our central hypotheses by pursuing the following two
specific aims: (1) To assess our novel point-of-care tenofovir (TFV) assay in whole blood and
urine specimens within a controlled pharmacokinetic study of HIV-negative adults receiving
tenofovir disoproxil fumarate (TDF) with low, moderate, and perfect adherence; and (2) To
validate our novel point-of-care tenofovir (TFV) assay on blood and urine specimens using an
existing biorepository from a real-world clinical HIV prevention study.
This work is innovative because it develops an entirely new category of rapid diagnostic
testing for monitoring ART and PrEP adherence at the clinical point of care. Our rapid assay
will help clinicians identify patients in need of more adherence counseling, which when
implemented will prevent HIV acquisition, emergence of drug resistant virus, and unnecessary
ART regimen switching-measures that will improve national HIV programs and help preserve the
global supply of an effective HIV medication.
Phase:
N/A
Details
Lead Sponsor:
University of Washington
Collaborators:
Chiang Mai University National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir