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Randomized Controlled Trial
. 2008 Apr 10;358(15):1560-71.
doi: 10.1056/NEJMoa0800260. Epub 2008 Mar 12.

Effect of herpes simplex suppression on incidence of HIV among women in Tanzania

Deborah Watson-Jones  1 , Helen A Weiss, Mary Rusizoka, John Changalucha, Kathy Baisley, Kokugonza Mugeye, Clare Tanton, David Ross, Dean Everett, Tim Clayton, Rebecca Balira, Louise Knight, Ian Hambleton, Jerome Le Goff, Laurent Belec, Richard Hayes; HSV trial team; Steering and Data Monitoring Committees
Collaborators, Affiliations
Randomized Controlled Trial

Effect of herpes simplex suppression on incidence of HIV among women in Tanzania

Deborah Watson-Jones et al. N Engl J Med. .

Erratum in

  • N Engl J Med. 2010 Apr 15;362(15):1450

Abstract

Background: Infection with herpes simplex virus type 2 (HSV-2) is associated with an increased risk of acquiring infection with the human immunodeficiency virus (HIV). This study tested the hypothesis that HSV-2 suppressive therapy reduces the risk of HIV acquisition.

Methods: Female workers at recreational facilities in northwestern Tanzania who were 16 to 35 years of age were interviewed and underwent serologic testing for HIV and HSV-2. We enrolled female workers who were HIV-seronegative and HSV-2-seropositive in a randomized, double-blind, placebo-controlled trial of suppressive treatment with acyclovir (400 mg twice daily). Participants attended mobile clinics every 3 months for a follow-up period of 12 to 30 months, depending on enrollment date. The primary outcome was the incidence of infection with HIV. We used a modified intention-to-treat analysis; data for participants who became pregnant were censored. Adherence to treatment was estimated by a tablet count at each visit.

Results: A total of 821 participants were randomly assigned to receive acyclovir (400 participants) or placebo (421 participants); 679 (83%) completed follow-up. Mean follow-up for the acyclovir and placebo groups was 1.52 and 1.62 years, respectively. The incidence of HIV infection was 4.27 per 100 person-years (27 participants in the acyclovir group and 28 in the placebo group), and there was no overall effect of acyclovir on the incidence of HIV (rate ratio for the acyclovir group, 1.08; 95% confidence interval, 0.64 to 1.83). The estimated median adherence was 90%. Genital HSV was detected in a similar proportion of participants in the two study groups at 6, 12, and 24 months. No serious adverse events were attributable to treatment with acyclovir.

Conclusions: These data show no evidence that acyclovir (400 mg twice daily) as HSV suppressive therapy decreases the incidence of infection with HIV. (Current Controlled Trials number, ISRCTN35385041 [controlled-trials.com].).

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Figures

Figure 1
Figure 1
Screening, Randomization, and Follow-up of Study Participants.
Figure 2
Figure 2
Kaplan–Meier Estimates of the Cumulative Percentage of Patients with HIV Infection, According to Study Group.
See this image and copyright information in PMC

Comment in

References

    1. Joint United Nations Programme on HIV/AIDS Report on the global AIDS epidemic. 2006. Accessed March 8, 2008, at http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/.
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    1. Watson-Jones D, Weiss H, Rusizoka M, et al. Risk factors for herpes simplex type 2 and HIV among women at high risk in northwestern Tanzania: preparing for an HSV-2 intervention trial. J Acquir Immune Defic Syndr. 2007;46:631–42. - PMC - PubMed
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