Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Colorado, Denver
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID) San Francisco Department of Public Health
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir