1. 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.
- Author
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Cowan, F. M., Pascoe, S. J., Barlow, K. L., Langhaug, L. F., Jaffar, S., Hargrove, J. W., Robinson, N. J., Bassett, M. T., Wilson, D., Brown, D. W. G., and Hayes, R. J.
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ACYCLOVIR , *HIV , *HERPES simplex virus , *HIV-positive women , *NUCLEOSIDES , *ANTIVIRAL agents , *HIV infection complications , *HERPESVIRUSES , *COMPARATIVE studies , *HERPES genitalis , *HIV infections , *RESEARCH methodology , *MEDICAL cooperation , *PATIENT compliance , *SEX work , *RESEARCH , *RESEARCH funding , *RURAL health , *STATISTICAL sampling , *VIRAL physiology , *VIRAL load , *EVALUATION research , *RANDOMIZED controlled trials , *ANTI-HIV agents , *DISEASE complications , *PHYSIOLOGY , *THERAPEUTICS - Abstract
Objectives: To determine the effect of daily acyclovir on genital shedding of HIV-1 and herpes simplex virus type 2 (HSV-2) in a randomised placebo-controlled trial among rural Zimbabwean sex workers.Methods: 214 women were recruited and tested for HIV-1 and HSV-2 antibodies, HIV plasma viral load, CD4 lymphocyte count and genital swabs for qualitative detection of HIV-1 and HSV-2 genital shedding. Women were randomly assigned to acyclovir 400 mg twice a day for 12 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 randomly assigned to acyclovir or placebo; 125 of whom were co-infected with HIV-1 and HSV-2. 69 women were randomly assigned to acyclovir and 56 to placebo. Although twice daily acyclovir reduced rates of HSV-2 genital shedding, (adjusted odds ratio (AOR) 0.24; 95% CI 0.12 to 0.48; less than p<0.001), it had no effect on the proportion of visits at which HIV-1 shedding was detected (AOR 1.08; 95% CI 0.48 to 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-seropositive women, suppressive acyclovir therapy had no effect on the rate of HIV genital shedding despite a reduction in genital HSV-2. Treatment adherence and its measurement clearly affect the interpretation of these results. [ABSTRACT FROM AUTHOR]- Published
- 2008
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