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用于预防女性感染艾滋病毒的SAVVY(C31G)凝胶:在加纳进行的一项3期双盲随机安慰剂对照试验。

SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana.

作者信息

Peterson Leigh, Nanda Kavita, Opoku Baafuor Kofi, Ampofo William Kwabena, Owusu-Amoako Margaret, Boakye Andrew Yiadom, Rountree Wes, Troxler Amanda, Dominik Rosalie, Roddy Ronald, Dorflinger Laneta

机构信息

Family Health International, Durham, North Carolina, United States.

出版信息

PLoS One. 2007 Dec 19;2(12):e1312. doi: 10.1371/journal.pone.0001312.

Abstract

OBJECTIVE

The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk.

METHODOLOGY/PRINCIPAL FINDINGS: This was a Phase 3, double-blind, randomized, placebo-controlled trial. Participants made up to 12 monthly visits for HIV testing, adverse event reporting, and study product supply. The study was conducted between March 2004 and February 2006 in Accra and Kumasi, Ghana. We enrolled 2142 HIV-negative women at high risk of HIV infection, and randomized them to SAVVY or placebo gel. Main outcome measures were the incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate specimens and adverse events. We accrued 790 person-years of follow-up in the SAVVY group and 772 person-years in the placebo group. No clinically significant differences in the overall frequency of adverse events, abnormal pelvic examination findings, or abnormal laboratory results were seen between treatment groups. However, more participants in the SAVVY group reported reproductive tract adverse events than in the placebo group (13.0% versus 9.4%). Seventeen HIV seroconversions occurred; eight in participants randomized to SAVVY and nine in participants receiving placebo. The Kaplan-Meier estimates of the cumulative probability of HIV infection through 12 months were 0.010 in the SAVVY group and 0.011 in the placebo group (p = 0.731), with a hazard ratio (SAVVY versus placebo) of 0.88 (95% confidence interval 0.33, 2.27). Because of a lower-than-expected HIV incidence, we were unable to achieve the required number of HIV infections (66) to obtain the desired study power.

CONCLUSIONS/SIGNIFICANCE: SAVVY was not associated with increased adverse events overall, but was associated with higher reporting of reproductive adverse events. Our data are insufficient to conclude whether SAVVY is effective at preventing HIV infection relative to placebo.

TRIAL REGISTRATION

ClinicalTrials.gov NCT00129532.

摘要

目的

本试验的目的是确定1.0% C31G(SAVVY)在预防高危女性中男性向女性阴道传播HIV感染方面的有效性。

方法/主要发现:这是一项3期双盲随机安慰剂对照试验。参与者每月最多进行12次HIV检测、不良事件报告和研究产品供应。该研究于2004年3月至2006年2月在加纳的阿克拉和库马西进行。我们招募了2142名HIV阴性且感染HIV风险高的女性,并将她们随机分为SAVVY组或安慰剂凝胶组。主要结局指标是通过检测口腔黏膜渗出液标本中的HIV抗体确定的HIV - 1和HIV - 2感染发生率以及不良事件。SAVVY组累计随访790人年,安慰剂组累计随访772人年。治疗组之间在不良事件总体频率、盆腔检查异常结果或实验室异常结果方面未见临床显著差异。然而,SAVVY组报告生殖道不良事件的参与者比安慰剂组更多(13.0%对9.4%)。发生了17例HIV血清转化;随机分配到SAVVY组的参与者中有8例,接受安慰剂的参与者中有9例。SAVVY组12个月时HIV感染累积概率的Kaplan - Meier估计值为0.010,安慰剂组为0.011(p = 0.731),风险比(SAVVY组对安慰剂组)为0.88(95%置信区间0.33,2.27)。由于HIV发病率低于预期,我们未能达到获得所需研究效能所需的HIV感染例数(66例)。

结论/意义:总体而言,SAVVY与不良事件增加无关,但与生殖不良事件报告率较高有关。我们的数据不足以得出SAVVY相对于安慰剂在预防HIV感染方面是否有效的结论。

试验注册

ClinicalTrials.gov NCT00129532

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2ba/2129116/148a4c0102a6/pone.0001312.g001.jpg

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