Tanton C., Weiss H.A., Rusizoka M., Legoff J., Changalucha J., Baisley K., Mugeye K., Everett D., Belec L., Clayton T.C., Ross D.A., Hayes R.J., Watson-Jones D.
London School of Hygiene and Tropical Medicine, London, United Kingdom; National Institute for Medical Research, Mwanza, Tanzania; African Medical and Research Foundation, Mwanza, Tanzania; Laboratoire de Microbiologie, Hôpital Saint Louis, Université Paris Descartes, Paris, France; Inserm U743, Université Paris Descartes, Paris, France; Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Chichiri, Blantyre, Malawi
Tanton, C., London School of Hygiene and Tropical Medicine, London, United Kingdom, National Institute for Medical Research, Mwanza, Tanzania; Weiss, H.A., London School of Hygiene and Tropical Medicine, London, United Kingdom; Rusizoka, M., African Medical and Research Foundation, Mwanza, Tanzania; Legoff, J., Laboratoire de Microbiologie, Hôpital Saint Louis, Université Paris Descartes, Paris, France; Changalucha, J., National Institute for Medical Research, Mwanza, Tanzania; Baisley, K., London School of Hygiene and Tropical Medicine, London, United Kingdom, National Institute for Medical Research, Mwanza, Tanzania; Mugeye, K., African Medical and Research Foundation, Mwanza, Tanzania; Everett, D., London School of Hygiene and Tropical Medicine, London, United Kingdom, National Institute for Medical Research, Mwanza, Tanzania, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Chichiri, Blantyre, Malawi; Belec, L., Inserm U743, Université Paris Descartes, Paris, France; Clayton, T.C., London School of Hygiene and Tropical Medicine, London, United Kingdom; Ross, D.A., London School of Hygiene and Tropical Medicine, London, United Kingdom; Hayes, R.J., London School of Hygiene and Tropical Medicine, London, United Kingdom; Watson-Jones, D., London School of Hygiene and Tropical Medicine, London, United Kingdom, African Medical and Research Foundation, Mwanza, Tanzania
Background. Herpes simplex virus (HSV) suppressive therapy reduces genital and plasma human immunodeficiency virus type 1 (HIV-1) RNA over periods up to 3 months, but the long-term effect is unknown. Methods. A total of 484 HIV-1 and HSV type 2 seropositive Tanzanian women aged 16-35 years were enrolled in a randomized placebo-controlled trial of acyclovir administered at a dosage of 400 mg twice daily. Cervicovaginal lavage and blood samples were collected at 6 months, 12 months, and 24 months for quantification of genital and plasma HIV-1 RNA and genital HSV DNA. Primary outcomes were detection and quantity of cervicovaginal HIV-1 RNA at 6 months. Results. At 6 months, there was little difference between the acyclovir and placebo arms for cervico-vaginal HIV-1 RNA detection (88 [41.3%] of 213 vs 84 [44.0%] of 191; odds ratio [OR], 0.90; 95% confidence interval [CI], 0.60-1.33), HSV DNA detection (20 [9.4%] of 213 vs 22 [11.5%] of 191; OR, 0.80; 95% CI, 0.42-1.51), genital HIV or HSV loads, or plasma HIV-1 RNA load. Estimated median adherence was 91%. There was a suggestion of an impact on cervico-vaginal HIV-1 RNA detection among women with estimated adherence 3≥90% (OR, 0.74; 95% CI, 0.50-1.09) when data from all 3 visits were included. Conclusions. Acyclovir administered at a dosage of 400 mg twice daily is unlikely to be a useful long-term intervention to reduce HIV transmission. The lack of effect on HIV may be attributable to suboptimal adherence or treatment regimen. © 2010 by the Infectious Diseases Society of America. All rights reserved.