International Partnership for Microbicides, Silver Spring, MD.
MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and.
J Acquir Immune Defic Syndr. 2020 Sep 1;85(1):51-57. doi: 10.1097/QAI.0000000000002397.
The dapivirine vaginal ring reduced the risk of HIV infection by approximately 30% in Phase III trials. To ensure higher levels of protection against HIV and sexually transmitted infections, women should be counseled to use condoms when using the vaginal ring. This article evaluates the compatibility of male condoms with a placebo vaginal ring.
This was a 2-period crossover, randomized, noninferiority trial. Couples in 2 sites in the United States were randomized to male condom use, with and without a placebo silicone vaginal ring, and asked to use 4 male condoms in each period. The primary noninferiority end points were total clinical failure and their component failure events (clinical breakage or slippage). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods using the male condom without the ring as reference. Noninferiority was defined using a 3% margin at the 5% significance level. Safety and acceptability were also assessed.
Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period. Total condom clinical failure rates were 2.2% and 4.0% in the presence and absence of the vaginal ring, respectively, with a difference of -1.9% (95% confidence interval: -5.3% to 1.5%), thereby demonstrating noninferiority when used with the ring. There was no difference in safety between the 2 periods.
Concurrent use of the placebo silicone vaginal ring had no significant effect on male condom functionality or safety outcomes.
在三期临床试验中，双汰芝阴道环可将艾滋病毒感染风险降低约 30%。为了确保更高水平的艾滋病毒和性传播感染防护，应建议女性在使用阴道环时使用安全套。本文评估了安慰剂阴道环与男用避孕套的兼容性。
这是一项两周期交叉、随机、非劣效性试验。美国两个地点的夫妇被随机分为两组，一组使用男用避孕套，一组同时使用安慰剂硅酮阴道环，并要求在每个周期使用 4 个男用避孕套。主要非劣效终点是总临床失败及其组成失败事件（临床破裂或滑脱）。计算了每种失败模式的频率和百分比，并使用无环男用避孕套作为参考，比较了两个周期的性能差异。非劣效性定义为在 5%的显著性水平下具有 3%的边界。还评估了安全性和可接受性。
70 对夫妇入组，68 对夫妇完成试验，每个周期共使用 275 个男用避孕套。有和没有阴道环时，避孕套总临床失败率分别为 2.2%和 4.0%，差异为-1.9%（95%置信区间：-5.3%至 1.5%），因此在使用时具有非劣效性。两个周期之间的安全性没有差异。
同时使用安慰剂硅酮阴道环对男用避孕套的功能或安全性结果没有显著影响。
