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Background  Use of antiretroviral-based microbicides for HIV-1 prophylaxis could introduce a transmission barrier that inadvertently facilitates the selection of fitter viral variants among incident infections. To investigate this, we assessed the in vitro function of  gag-protease  and  nef  sequences from participants who acquired HIV-1 during the CAPRISA 004 1% tenofovir microbicide gel trial.    Methods and Results  We isolated the earliest available  gag-protease  and  nef  gene sequences from 83 individuals and examined their in vitro function using recombinant viral replication capacity assays and surface protein downregulation assays, respectively. No major phylogenetic clustering and no significant differences in  gag-protease  or  nef  function were observed in participants who received tenofovir gel versus placebo gel prophylaxis.    Conclusion  Results indicate that the partial protective effects of 1% tenofovir gel use in the CAPRISA 004 trial were not offset by selection of transmitted/early HIV-1 variants with enhanced Gag-Protease or Nef fitness.

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No Evidence for Selection of HIV-1 with Enhanced Gag-Protease or Nef Function among Breakthrough Infections in the CAPRISA 004 Tenofovir Microbicide Trial