Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.
Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.
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DOI：
10.1371/journal.pmed.0020298
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发表时间：
2005-11
期刊：
影响因子：
15.8
通讯作者：
Puren A
中科院分区：
文献类型：
--
作者：
Auvert B;Taljaard D;Lagarde E;Sobngwi-Tambekou J;Sitta R;Puren A
观察性研究表明，男性包皮环切术可能提供保护，防止艾滋病毒-1感染。在南非的一般人群中进行了一项随机对照干预试验，以检验这一假设。共有3，274名年龄在18-24岁的未行包皮环切术的男性被随机分配到对照组或干预组，并在第3、12和21个月进行随访。干预组在随机分组后立即接受男性包皮环切术，对照组在随访结束时接受包皮环切术。使用分段指数比例风险模型，在意向治疗、单变量和多变量分析中分析分组删失数据。确定HIV发病率的率比（RR）及其95%CI。对艾滋病毒感染的保护计算为1 − RR。试验在中期分析时停止，分析数据时的平均（四分位距）随访时间为18.1个月（13.0-21.0）。干预组有20例HIV感染（发病率= 0.85/100人-年），对照组有49例（2.1/100人-年），相应的RR为0.40（95% CI：0.24%-0.68%; p < 0.001）。该RR相当于60%的保护（95% CI：32%-76%）。当控制行为因素时，包括干预组中略有增加的性行为、安全套使用和寻求健康的行为，保护率为61%（95%CI：34%-77%）。男性包皮环切术提供了一定程度的保护，防止艾滋病毒感染，相当于高效力疫苗所能达到的效果。男性包皮环切术可能是减少撒哈拉以南非洲艾滋病毒感染蔓延的一个重要途径。（初步结果和部分结果已提交2005年7月26日在巴西里约热内卢举行的国际艾滋病学会2005年会议。第一次男性包皮环切术降低艾滋病毒风险的试验发现，治疗组的新病例明显减少。
Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. A total of 3,274 uncircumcised men, aged 18–24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR) of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 − RR. The trial was stopped at the interim analysis, and the mean (interquartile range) follow-up was 18.1 mo (13.0–21.0) when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years) in the intervention group and 49 (2.1 per 100 person-years) in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%–0.68%; p < 0.001). This RR corresponds to a protection of 60% (95% CI: 32%–76%). When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%–77%). Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil.) The first trial of male circumcision for reducing the risk of HIV finds significantly lower new cases in the treatment group.
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DOI：
10.1097/00126334-200405010-00010
发表时间：
2004-05-01
影响因子：
3.6
作者：
Auvert, B;Males, S;Williams, B
通讯作者：
Williams, B
影响因子：
3.8
作者：
BONGAARTS, J;REINING, P;CONANT, F
通讯作者：
CONANT, F
影响因子：
3.6
作者：
Kebaabetswe, P;Lockman, S;Shapiro, RL
通讯作者：
Shapiro, RL
影响因子：
6.4
作者：
Lavreys, L;Rakwar, JP;Kreiss, JK
通讯作者：
Kreiss, JK
影响因子：
3
作者：
Caldwell, JC;Caldwell, P
通讯作者：
Caldwell, P