Fogel JM, Wang L, Parsons TL, Ou SS, Piwowar-Manning E, Chen Y, Mudhune VO, Hosseinipour MC, Kumwenda J, Hakim JG, Chariyalertsak S, Panchia R, Kumarasamy N, Grinsztejn B, Makhema J, Pilotto J, Santos BR, Mayer KH, McCauley M, Gamble T, et. Al, Bumpus N, Hendrix C, Cohen M, Eshleman S. Undisclosed antiretroviral drug use in a multinational clinical trial (HIV Prevention Trials Network 052). J Infect Dis. 2013, 208: 1624-8. PMC3805242
The HIV Prevention Trials Network (HPTN) 052 enrolled serodiscordant couples. HIV-infected index participants reported no prior antiretroviral (ARV) treatment at enrollment. ARV drug testing was performed retrospectively using enrollment samples from a subset of index participants. ARV drugs were detected in 45/96 (46.9%) participants with undetectable viral load (VL), 2/48 (4.2%) participants with low VL, and 1/65 (1.5%) participants with high VL (P<0.0001). ARV drugs were also detected in follow-up samples from participants who were not on study-administered treatment. ARV drug testing may be useful in addition to self-report of ARV drug use in some clinical trial settings.