MTN-009

Primary Objective

• Assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials

Study Summary
MTN-009 was a multi-site, cross-sectional study that provided an estimate of the prevalence of antiretroviral (ARV) drug resistance mutations in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. Limited data exist on the prevalence of HIV infection or HIV drug resistance among individuals who are potential users of ARV-based prevention products. Secondary objectives included: 1) the identification and evaluation of behavioral indicators including self or sexual partner(s) exposures to ARV drugs as risk factors for drug resistant HIV infection; and 2) characterization of the degree of immunodeficiency and risk of disease progression by quantifying plasma HIV-1 RNA and CD4-positive T cells among women who test HIV-positive when presenting to screen for participation in an HIV prevention trial. Exploratory objectives included the identification of polymorphic or subtype-specific sequence changes in HIV-1 that may impact susceptibility to ARVs and the estimation of the proportion of HIV-positive women who have chronic versus recent HIV infection.

MTN-009 completed follow-up on March 24, 2011. Preliminary results were presented at the 2012 Retroviruses and Opportunistic Infections (CROI) held on March 5-8, 2012, in Seattle, WA. The primary manuscript was published in PLoS One on April 9, 2013. A total of two papers have been published from this study.

Primary Results
Of the 1075 participants enrolled in MTN-009, 1073 were considered to be evaluable.  Of these, 400 (37%) had confirmed HIV infection. Of those, 91% (365/400) had detectable plasma HIV-1 RNA (>40 copies/ml). 156 women (39%) were eligible for antiretroviral therapy (CD4<350 cells/mm3) and 50 (13%) met criteria for AIDS (CD4<200 cells/mm3). Of 352 plasma samples analyzed for drug resistance, 26 (7.4%) had nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) drug resistance mutations. Among those with resistance, 18/26 participants (62%) had single-class NNRTI resistance and 5/26(19%) had dual-class NRTI/NNRTI. All participants were infected with subtype C virus, except one infected with subtype A. Effective screening to exclude HIV infection among women interested in uptake of ARV based HIV prevention will be essential in limiting the spread of HIV drug resistance.