预防HIV-1感染的PRO2000阴道凝 (杀菌剂开发计划301):一个第三阶段,随机,双盲,并行组试验
Sheena McCormack1, Gita Ramjee, Anatoli Kamali
1MRC Clinical Trials Unit, London, UK. smc@ctu.mrc.ac.uk
Lancet (London, England)
|September 21, 2010
概括
为了防止女性感染HIV-1病毒,经过测试的PRO2000阴道凝被发现是安全的,但不有效. 这项研究强调了对新型HIV-1预防方法的持续研究的需要.
科学领域:
- 病毒学 病毒学
- 公共卫生 公共卫生
- 临床试验 临床试验
背景情况:
- 创新策略对于预防HIV-1传播至关重要.
- 在研究中,PRO2000阴道凝显示出有效性.
- 这项研究旨在评估撒哈拉以南非洲妇女的PRO2000凝.
研究的目的:
- 评估2%和0.5%的PRO2000阴道凝对HIV-1传播的有效性和安全性.
- 提供关于杀菌剂在妇女中的有效性的数据.
主要方法:
- 第三阶段,随机,双盲,安慰剂对照试验 (杀菌剂开发计划301).
- 9385名女性被随机分配到2%的PRO2000,0.5%的PRO2000或安慰剂凝组.
- 主要疗效结局是到第52周的HIV-1发病率;安全终点是3级或更严重的不良事件.
主要成果:
- 所有组的HIV-1发病率相似:每100个女性年4.5% (0.5%PRO2000) 与4.3% (安慰剂) 相比.
- 2% PRO2000凝使用由于益处概率低而提前停止.
- 在0.5%的PRO2000和安慰剂组中,安全性概况是可比的.
结论:
- 0.5%和2%的PRO2000阴道凝在预防阴道HIV-1传播方面无效.
- PRO2000凝不适用于女性的HIV-1预防.
- 对有效的HIV-1预防策略的进一步研究是必要的.
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