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A randomised placebo controlled trial to explore the effect of suppressive therapy with acyclovir on genital shedding of HIV-1 and herpes simplex virus type 2 among Zimbabwean sex workers
  1. Frances M Cowan (frances{at}uz-ucsf.co.zw)
  1. University College London, United Kingdom
    1. Sophie Pascoe (sophie.pascoe{at}lshtm.ac.uk)
    1. LSHTM, United Kingdom
      1. Katrina Barlow (katrina.barlow{at}hpa.org.uk)
      1. Health Protection Agency, United Kingdom
        1. Lisa Langhaug (fox{at}africaonline.co.zw)
        1. UCL, United Kingdom
          1. Shabbar Jaffar (shabbar.jaffar{at}lshtm.ac.uk)
          1. LSHTM, United Kingdom
            1. John Hargrove (jhargrove{at}sun.ac.za)
            1. University of Zimbabwe, Zimbabwe
              1. Noah Robinson (jamie.robinson{at}roche.com)
              1. GlaxoSmithKline, Zimbabwe
                1. Mary T Bassett (marytravisbassett{at}yahoo.com)
                1. University of Zimbabwe, Zimbabwe
                  1. David Wilson (dwilson{at}gmx.net)
                  1. University of Zimbabwe, Zimbabwe
                    1. David WG Brown (david.brown{at}hpa.org.uk)
                    1. Health Protection Agency, United Kingdom
                      1. Richard J Hayes (richard.hayes{at}lshtm.ac.uk)
                      1. LSHTM, United Kingdom

                        Abstract

                        Objectives: To determine the effect of daily acyclovir on genital shedding of HIV-1 and HSV-2 in a randomised placebo controlled trial among rural Zimbabwean sex workers.

                        Methods: Two hundred and fourteen women were recruited and tested for HIV-1 and HSV-2 antibodies, HIV plasma viral load (PVL), CD4 lymphocyte count and genital swabs for qualitative detection of HIV-1 and HSV-2 genital shedding. Women were randomised to acyclovir 400mg twice daily for twelve weeks or matching placebo and were followed weekly to detect HIV-1 or HSV-2 genital shedding. Shedding analyses were only undertaken on 125 women co-infected with HSV-2 and HIV-1. Data were analysed using logistic regression, with random effects modelling used to account for repeated measurements on the same women.

                        Results: All women were randomised to acyclovir or placebo; 125 of whom were co-infected with HIV-1 and HSV-2. Sixty nine women were randomised to acyclovir and 56 to placebo. Although twice daily acyclovir reduced rates of HSV-2 genital shedding, (adjusted OR 0.24 (95% CI 0.12-0.48; p<0.0001)), it had no effect on the proportion of visits at which HIV-1 shedding was detected (adjusted OR 1.08 (95% CI 0.48-2.42; p=0.9)). Adherence varied between participants but even when adherence was high (as determined by pill count and extent of HSV-2 suppression) HIV-1 shedding was not reduced.

                        Conclusion: Among these HIV-1 and HSV-2 sero-positive women, suppressive acyclovir therapy had no effect on the rate of HIV genital shedding despite reduction in genital HSV-2. Treatment adherence and its measurement clearly affect interpretation of these results.

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