Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial.
Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial.
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DOI：
10.1016/s0140-6736(09)60998-3
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发表时间：
2009-07-18
期刊：
影响因子：
168.9
通讯作者：
Gray, Ronald H.
中科院分区：
文献类型：
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作者：
Wawer, Maria J.;Makumbi, Frederick;Kigozi, Godfrey;Serwadda, David;Watya, Stephen;Nalugoda, Fred;Buwembo, Dennis;Ssempijja, Victor;Kiwanuka, Noah;Moulton, Lawrence H.;Sewankambo, Nelson K.;Reynolds, Steven J.;Quinn, Thomas C.;Opendi, Pius;Iga, Boaz;Ridzon, Renee;Laeyendecker, Oliver;Gray, Ronald H.
在感染艾滋病毒的男性中进行了一项男性包皮环切术(MC)的随机试验，以检验MC将减少艾滋病毒传播给女性性伴侣的假设。这项在乌干达拉凯区进行的随机、非盲目试验，招募了922名年龄在15-49岁、CD4计数为≥350的未接受割礼、感染艾滋病毒的无症状男性。男性被随机分配到立即包皮环切术(干预组)或延迟24个月的包皮环切组(对照组)。同时登记的HIV阴性的女性伴侣在6个月、12个月和24个月时被随访，以评估男性MC分配的HIV感染(主要结果)。一项意向治疗分析使用生存分析和COX比例风险模型评估了妇女感染艾滋病毒的情况。该试验在临床试验.gov协议注册系统(NCT00124878)中注册。审判因徒劳无功而终止。93名同时入选的干预组男性女性伴侣和70名对照组男性伴侣提供了随访数据。24个月时干预组女性感染HIV的累计概率为21.7%(95%可信区间12.7~33.4)，对照组为13.4%(95%可信区间6.7~25.8)(调整危险比=1.49，95%可信区间0.62~3.57，p=0.368)。在6个月时，在证实的手术伤口愈合前5天恢复性交的夫妇中，干预性交从男性传播到女性的比例为27.8%(5/18)，而手术后戒除时间较长的夫妇为9.5%(6/63，p=0.06)，对照组为7.9%(5/63，p=0.04)。对感染≥的男性进行包皮环切术并不能减少24个月后艾滋病毒向女性伴侣的传播，术后早期恢复性行为可能会增加传播风险。更长期的影响无法评估。手术后的性节制和随后一致的避孕套是预防艾滋病毒的关键。
A randomized trial of male circumcision (MC) was conducted among HIV-infected males to test the hypothesis that MC would reduce HIV transmission to female sexual partners. This randomized, unblinded trial, conducted in Rakai District, Uganda, enrolled 922 uncircumcised, HIV-infected asymptomatic men aged 15–49 with CD4 counts ≥350. Men were randomly assigned to immediate circumcision (intervention) or circumcision delayed for 24 months (control). Concurrently enrolled HIV-negative female partners were followed up at 6, 12 and 24 months, to assess HIV acquisition by male MC assignment (primary outcome). An intention-to-treat analysis assessed women’s HIV acquisition using survival analysis and Cox proportional hazards modeling. The trial was registered in the Clinical Trials.gov Protocol Registration System (NCT00124878). The trial was terminated for futility. Ninety three concurrently enrolled female partners of intervention arm men and 70 partners of control arm men provided follow up data. Cumulative probabilities of female HIV infection at 24 months were 21.7% (95% CI 12.7–33.4) in the intervention arm and 13.4% (95% CI 6.7–25.8) in the control arm (adjusted hazard ratio= 1.49, 95% CI 0.62–3.57, p = 0.368). At 6 months, intervention arm male-to-female transmission in couples who resumed intercourse ≥5 days prior to certified surgical wound healing was 27.8% (5/18), compared to 9.5% in couples who abstained longer post-surgically (6/63, p = 0.06) and 7.9% in control arm couples (5/63, p = 0.04) Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months, and transmission risk may be increased with early post-surgical resumption of intercourse. Longer-term effects could not be assessed. Post surgical sexual abstinence and subsequent consistent condom are essential for HIV prevention.