Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission
Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission
复制标题
DOI：
10.1056/nejmoa0707957
复制
发表时间：
2008-07-31
影响因子：
158.5
通讯作者：
Taylor, Doug
中科院分区：
文献类型：
--
作者：
Van Damme, Lut;Govinden, Roshini;Taylor, Doug
背景资料：在撒哈拉以南非洲，感染人体免疫缺陷病毒（艾滋病毒）或后天免疫缺陷综合症（艾滋病）的成年人中，妇女占50%以上。因此，女性发起的HIV预防方法是迫切需要的。方法：我们进行了一项随机，双盲，安慰剂对照试验的纤维素硫酸盐，HIV进入抑制剂配制为阴道凝胶，涉及妇女在三个非洲和两个印度网站的HIV感染的高风险。主要终点是新获得的HIV 1型或2型感染。次要终点是新获得的淋球菌或衣原体感染。主要分析是基于对数秩检验没有差异的时间分布到HIV感染，分层根据site.Results：共1398名妇女参加，并随机分配到接受硫酸纤维素凝胶（706名参与者）或安慰剂（692名参与者），并有后续的HIV检测数据。有41例新发HIV感染，硫酸纤维素组25例，安慰剂组16例，硫酸纤维素组感染的估计风险比为1.61（P=0.13）。该结果不具有显著性，与导致试验提前停止的中期结果（风险比，2.23; P=0.02）和预先计划的次要（基于依从性）分析的提示性结果（风险比，2.18; P=0.03）形成对比。与安慰剂相比，硫酸纤维素对淋病感染（危害比，1.10; 95%置信区间[CI]，0.74至1.62）或衣原体感染（危害比，0.71; 95%CI，0.47至1.08）的风险无显著影响。结论：硫酸纤维素不能预防HIV感染，并可能增加HIV感染的风险。（ClinicalTrials.gov编号，NCT 00153777;和当前对照试验编号，ISRCTN 95638385）。
Background: Women make up more than 50% of adults living with human immunodeficiency virus (HIV) infection or the acquired immunodeficiency syndrome (AIDS) in sub-Saharan Africa. Thus, female-initiated HIV prevention methods are urgently needed.Methods: We performed a randomized, double-blind, placebo-controlled trial of cellulose sulfate, an HIV-entry inhibitor formulated as a vaginal gel, involving women at high risk for HIV infection at three African and two Indian sites. The primary end point was newly acquired infection with HIV type 1 or 2. The secondary end point was newly acquired gonococcal or chlamydial infection. The primary analysis was based on a log-rank test of no difference in the distribution of time to HIV infection, stratified according to site.Results: A total of 1398 women were enrolled and randomly assigned to receive cellulose sulfate gel (706 participants) or placebo (692 participants) and had follow-up HIV test data. There were 41 newly acquired HIV infections, 25 in the cellulose sulfate group and 16 in the placebo group, with an estimated hazard ratio of infection for the cellulose sulfate group of 1.61 (P=0.13). This result, which is not significant, is in contrast to the interim finding that led to the trial being stopped prematurely (hazard ratio, 2.23; P=0.02) and the suggestive result of a preplanned secondary (adherence-based) analysis (hazard ratio, 2.18; P=0.03). No significant effect of cellulose sulfate as compared with placebo was found on the risk of gonorrheal infection (hazard ratio, 1.10; 95% confidence interval [CI], 0.74 to 1.62) or chlamydial infection (hazard ratio, 0.71; 95% CI, 0.47 to 1.08).Conclusions: Cellulose sulfate did not prevent HIV infection and may have increased the risk of HIV acquisition. (ClinicalTrials.gov number, NCT00153777; and Current Controlled Trials number, ISRCTN95638385.).