Failure to Identify HIV-infected Individuals in a Clinical Trial Using a Single HIV Rapid Test for Screening

Piwowar-Manning, Estelle; Fogel, Jessica M.; Laeyendecker, Oliver; Shauna Wolf; Cummings, Vanessa; Marzinke, Mark A.; Clarke, William; Breaud, Autumn; Wendel, Sarah; Lei Wang; Swanson, Priscilla; Hackett Jr., John; Mannheimer, Sharon; del Rio, Carlos; Kuo, Irene; Harawa, Nina T.; Koblin, Beryl A.; Moore, Richard; Blankson, Joel N.; Eshleman, Susan H.
March 2014
HIV Clinical Trials;Mar/Apr2014, Vol. 15 Issue 2, p62
Academic Journal
Background: In the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing. Objectives: To evaluate the performance of different HIV assays for detection of HIV infection in HPTN 061 participants with missed infection and individuals with viral suppression. Methods: Plasma samples from 8 HPTN 061 participants, 17 elite controllers, and 101 individuals on antiretroviral treatment (ART) were tested for HIV with 3 rapid tests, 2 laboratory-based immunoassays, and a Western blot assay. The HPTN 061 samples were also tested with 2 HIV RNA assays and an antiretroviral drug assay. Results: Of the 8 HPTN 061 participants with missed infection, 1 was an elite controller, 1 was taking ART, 2 were missed because of testing or clerical errors, 1 had recent HIV infection (Identified using a multi-assay algorithm), and 3 had acute HIV infection. Two (1.7%) of 118 individuals with viral suppression (both taking ART) had at least 1 false-negative test. Conclusions: In clinical trials, HIV infections can be missed for a variety of reasons. Using more than one assay to screen for HIV infection may reduce the number of missed infections.


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