Failure to Identify HIV-Infected Individuals in a Clinical Trial Using a Single HIV Rapid Test for Screening. Issue 2 (March 2014)

• Record Type: Journal Article
• Authors: Piwowar-Manning, Estelle; Fogel, Jessica M.; Laeyendecker, Oliver; Wolf, Shauna; Cummings, Vanessa; Marzinke, Mark A.; Clarke, William; Breaud, Autumn; Wendel, Sarah; Wang, Lei; Swanson, Priscilla; Hackett, John; , Jr; Mannheimer, Sharon; del Rio, Carlos; Kuo, Irene; Harawa, Nina T.; Koblin, Beryl A.; Moore, Richard; Blankson, Joel N.; Eshleman, Susan H.
• Is Part Of: HIV clinical trials. Volume 15:Issue 2(2014)
• Page Start: 62
• Page End: 68
• Publication Date: 2014-03
• Subjects: antiretroviral therapy, -- elite controller, -- HIV, -- rapid test, -- viral suppression; HIV Infections -- Chemotherapy -- Periodicals; AIDS (Disease) -- Chemotherapy -- Periodicals; HIV Infections -- Research -- Periodicals; AIDS (Disease) -- Research -- Periodicals; 616.979206105
• DOI: 10.1310/hct1502-62
• Languages: English
• ISSNs: 1528-4336

Abstract

Abstract : 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.