Effect of herpes simplex suppression on incidence of HIV among women in Tanzania.
Effect of herpes simplex suppression on incidence of HIV among women in Tanzania.
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DOI：
10.1056/nejmoa0800260
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发表时间：
2008-04-10
期刊：
影响因子：
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通讯作者：
Steering and Data Monitoring Committees
中科院分区：
文献类型：
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作者：
Watson-Jones D;Weiss HA;Rusizoka M;Changalucha J;Baisley K;Mugeye K;Tanton C;Ross D;Everett D;Clayton T;Balira R;Knight L;Hambleton I;Le Goff J;Belec L;Hayes R;HSV trial team;Steering and Data Monitoring Committees
2 型单纯疱疹病毒 (HSV-2) 感染与人类免疫缺陷病毒 (HIV) 感染风险增加相关。这项研究检验了 HSV-2 抑制治疗可降低感染 HIV 风险的假设。坦桑尼亚西北部娱乐设施中 16 至 35 岁的女工接受了采访，并接受了 HIV 和 HSV-2 血清学检测。我们招募了 HIV 血清阴性和 HSV-2 血清阳性的女性工人参加一项阿昔洛韦（400 毫克，每天两次）抑制治疗的随机、双盲、安慰剂对照试验。参与者每 3 个月去一次流动诊所，随访期为 12 至 30 个月，具体取决于注册日期。主要结果是艾滋病毒感染率。我们使用了修改后的意向治疗分析；怀孕参与者的数据受到审查。通过每次就诊时的药片计数来评估对治疗的依从性。总共 821 名参与者被随机分配接受阿昔洛韦（400 名参与者）或安慰剂（421 名参与者）； 659 人 (80%) 完成了随访。阿昔洛韦组和安慰剂组的平均随访时间分别为 1.52 和 1.62 年。 HIV 感染发生率为每 100 人年 4.27 例（阿昔洛韦组 27 名受试者，安慰剂组 28 名受试者），阿昔洛韦对 HIV 发病率没有总体影响（阿昔洛韦组比率为 1.08；95% 置信区间为 0.64 至 1.83）。估计中位依从率为 90%。在 6、12 和 24 个月时，两个研究组的参与者中检测到生殖器 HSV 的比例相似。无严重不良事件可归因于阿昔洛韦治疗。这些数据表明，没有证据表明阿昔洛韦（400 毫克，每天两次）作为 HSV 抑制疗法可以降低 HIV 感染的发生率。 （当前对照试验编号，ISRCTN35385041。）
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. 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. A total of 821 participants were randomly assigned to receive acyclovir (400 participants) or placebo (421 participants); 659 (80%) 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. 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.)