Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.
Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.
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DOI：
10.1097/qad.0b013e32834541d9
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发表时间：
2011-04-24
期刊：
影响因子：
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通讯作者：
HIV Prevention Trials Network (HPTN) 035 Study Team
中科院分区：
文献类型：
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作者：
Abdool Karim SS;Richardson BA;Ramjee G;Hoffman IF;Chirenje ZM;Taha T;Kapina M;Maslankowski L;Coletti A;Profy A;Moench TR;Piwowar-Manning E;Mâsse B;Hillier SL;Soto-Torres L;HIV Prevention Trials Network (HPTN) 035 Study Team
为了确定BufferGel和0.5% PRO2000杀菌剂凝胶预防HIV男性向女性传播的安全性和有效性，进行了一项随机、安慰剂对照试验，包括三个双盲凝胶组和一个开放标签无凝胶组。来自马拉维、南非、赞比亚、津巴布韦和美国的研究参与者被要求在每次性行为前≤1小时使用研究凝胶，并在随访期间评估安全性、性行为、怀孕、凝胶依从性、可接受性和HIV血清状态。3101名入组妇女平均随访20.4个月，93.6%的保留率和81.1%的自我报告凝胶粘附性。所有研究组的不良事件发生率相似。0.5% PRO2000凝胶、BufferGel、安慰剂凝胶和No凝胶组的HIV感染率分别为每100名妇女年2.70、4.14、3.91和4.02。0.5% PRO2000凝胶组的HIV发病率低于安慰剂凝胶组(风险比(HR)=0.7；p=0.10)和No Gel组（HR=0.67; p=0.06）。在BufferGel和安慰剂凝胶组（HR=1.10; p=0.63）和No Gel对照组（HR=1.05; p=0.78）中，HIV发病率相似。安慰剂凝胶组和无凝胶组的HIV发病率相似（HR=0.97; p=0.89）。0.5% PRO2000凝胶显示，妇女感染艾滋病毒的几率适度降低了30%。然而，这些结果在统计学上并不显著，随后的MDP 301试验结果证实0.5% PRO2000几乎没有保护作用。BufferGel并没有改变HIV感染的风险。两种产品都是安全的。
To determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male to female HIV transmission Phase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open label no gel arm. Study participants from Malawi, South Africa, Zambia, Zimbabwe and USA were instructed to apply study gel ≤1 hour before each sex act and safety, sexual behavior, pregnancy, gel adherence, acceptability, and HIV serostatus were assessed during follow-up. The 3101 enrolled women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in all study arms. HIV incidence rates in the 0.5% PRO2000 Gel, BufferGel, Placebo Gel and No Gel arms were 2.70, 4.14, 3.91 and 4.02 per 100 women-years, respectively. HIV incidence in the 0.5% PRO2000 Gel arm was lower than the Placebo Gel arm (Hazard Ratio (HR)=0.7; p=0.10) and the No Gel arm (HR=0.67; p=0.06). HIV incidence rates were similar in the BufferGel and both Placebo Gel (HR=1.10; p=0.63) and No Gel control arms (HR=1.05; p=0.78). HIV incidence was similar in the Placebo Gel and No Gel arms (HR=0.97; p=0.89). 0.5% PRO2000 Gel demonstrated a modest 30% reduction in HIV acquisition in women. However, these results were not statistically significant and subsequent findings from the MDP 301 trial have confirmed that 0.5% PRO2000 has little or no protective effect. BufferGel did not alter the risk of HIV infection. Both products were safe.