Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide
Status:
Completed
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
Summary
Pre-exposure prophylaxis (PrEP) with Truvada™ (tenofovir/emtricitabine), in which an
HIV-uninfected individual at high risk for contracting HIV takes antiretroviral medications
(one pill daily) to maintain blood and genital drug levels sufficient to prevent HIV-1
acquisition, has been validated in several large international trials that have included men
who have sex with men and transgender women, heterosexual men and women, and people who use
injection drugs, as a potential HIV-1 prevention strategy. HIV prevention interventions such
as this, if adequately disseminated and implemented broadly, may help to curb new HIV
infections, reduce HIV-associated morbidity and mortality, and reduce health disparities in
HIV rates among the most at-risk individuals. Assuring adherence to a daily dose of PrEP is
critical for effective protection against HIV infection. A urine-based test to measure PrEP
medication levels in the body represents a non-invasive technique to assess adherence and
ultimately improve PrEP's protective ability.
TAF/FTC (Descovy™) is a new medication under study for HIV prevention to see if it is as
effective as Truvada™. This study is testing whether a urine test can detect this medication
in urine.