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New study on pre-exposure prophylaxis (PrEP) at GGD Amsterdam: DISCOVER study
DISCOVER is a medical-scientific study which will research whether a new experimental medicine is safe and effective for use by healthy adults to prevent HIV infections. Preventing an HIV infection prior to being exposed to the risk for HIV is also known as pre-exposure prophylaxis (PrEP). The experimental medicine evaluated in this study is a pill that contains both emtricitabine and tenofovir alafenamide (F/TAF). The target group will be men and transgender women who have sex with men.
By random allocation, you will either receive the experimental PrEP medicine F/TAF, or Truvada® (which contains emtricitabine and tenofovir disoproxil fumarate). You and your study doctor/study nurse will not know which study medicine you will be using. Both Truvada® and F/TAF have been approved for use by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as part of chronic HIV treatment. Only Truvada® has been approved for use as PrEP in the United States, Canada and the European Union. The usage of F/TAF for PrEP is investigational and may not be efficacious.
The DISCOVER study was initiated and is financed by the pharmaceutical company GILEAD Sciences, Inc., Foster City, US.
A total of approximately 5000 subjects at about 100 sites in North-America and Europe will be participating in this international, medical-scientific study. The number of people that may participate in the study in the Netherlands depends on the speed with which the total number of participants is reached internationally. We received a total of 663 registrations for this study. We expect that approximately 100-150 persons will be able to participate in this study in the Netherlands. From the end of March until the end of June people that have registered during the registration period will be invited for a screening visit by email or by telephone. It is not possible anymore to register for this study.
For more information regarding this study, you may send an e-mail to firstname.lastname@example.org. Or, you may contact (020) 555 3999 by telephone.