Open AccessStudy Design Considerations for Evaluating Efficacy of Systemic Preexposure Prophylaxis Interventions
Author(s) -
Deborah Donnell,
James P. Hughes,
Lei Wang,
Ying Qing Chen,
Thomas R. Fleming
Publication year - 2013
Publication title -
journal of acquired immune deficiency syndromes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.162
H-Index - 157
eISSN - 1944-7884
pISSN - 1525-4135
DOI - 10.1097/qai.0b013e3182986fac
Subject(s) - emtricitabine , pre exposure prophylaxis , medicine , dosing , clinical trial , psychological intervention , placebo , food and drug administration , efficacy , human immunodeficiency virus (hiv) , clinical endpoint , clinical study design , research design , intensive care medicine , drug , alternative medicine , pharmacology , family medicine , viral load , antiretroviral therapy , psychiatry , men who have sex with men , social science , syphilis , pathology , sociology
The development of interventions for systemic pre-exposure prophylaxis (PrEP) faces several significant challenges following the US Food and Drug Administration's approval of emtricitabine/tenofovir (FTC/TDF) for HIV prevention. This development is particularly complex because of inconsistency of efficacy results of FTC/TDF PrEP trials for HIV prevention.