Gnatienko Natalia, Freiberg Matthew S, Blokhina Elena, Yaroslavtseva Tatiana, Bridden Carly, Cheng Debbie M, Chaisson Christine E, Lioznov Dmitry, Bendiks Sally, Koerbel Glory, Coleman Sharon M, Krupitsky Evgeny, Samet Jeffrey H
a Department of Medicine, Section of General Internal Medicine , Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit , Boston , MA , USA.
b Vanderbilt Center for Clinical Cardiovascular Trials Evaluation (V-C3REATE) , Vanderbilt University Medical Center , Nashville , TN , USA.
HIV Clin Trials. 2018 Jun;19(3):101-111. doi: 10.1080/15284336.2018.1459344. Epub 2018 Apr 17.
Background Russia continues to have an uncontrolled HIV epidemic and its per capita alcohol consumption is among the highest in the world. Alcohol use among HIV-positive individuals is common and is associated with worse clinical outcomes. Alcohol use and HIV each lead to microbial translocation, which in turn results in inflammation. Zinc supplementation holds potential for lowering levels of biomarkers of inflammation, possibly as a consequence of its impact on intestinal permeability. This paper describes the protocol of a double-blinded randomized placebo-controlled trial of zinc supplementation in St. Petersburg, Russia. Methods Participants (n = 254) were recruited between October 2013 and June 2015 from HIV and addiction clinical care sites, and non-clinical sites in St. Petersburg, Russia. Participants were randomly assigned, to receive either zinc (15 mg for men; 12 mg for women) or placebo, daily for 18 months. The following outcomes were assessed at 6, 12, and 18 months: (1) mortality risk (primary outcome at 18 months); (2) HIV disease progression; (3) cardiovascular risk; and (4) microbial translocation and inflammation. Adherence was assessed using direct (riboflavin) and indirect (pill count, self-report) measures. Conclusion Given the limited effectiveness of current interventions to reduce alcohol use, zinc supplementation merits testing as a simple, low-cost intervention to mitigate the consequences of alcohol use in HIV-positive persons despite ongoing drinking.
背景 俄罗斯的艾滋病疫情仍处于失控状态，其人均酒精消费量位居世界前列。艾滋病毒呈阳性的个体中饮酒现象普遍，且与更差的临床结果相关。饮酒和感染艾滋病毒都会导致微生物易位，进而引发炎症。补充锌有可能降低炎症生物标志物的水平，这可能是其对肠道通透性产生影响的结果。本文描述了在俄罗斯圣彼得堡进行的一项关于补充锌的双盲随机安慰剂对照试验的方案。方法 在2013年10月至2015年6月期间，从俄罗斯圣彼得堡的艾滋病毒和成瘾临床护理场所及非临床场所招募了参与者（n = 254）。参与者被随机分配，每天接受锌（男性15毫克；女性12毫克）或安慰剂，为期18个月。在6个月、12个月和18个月时评估以下结果：（1）死亡风险（18个月时的主要结果）；（2）艾滋病毒疾病进展；（3）心血管风险；以及（4）微生物易位和炎症。使用直接（核黄素）和间接（药丸计数、自我报告）措施评估依从性。结论 鉴于目前减少饮酒干预措施的效果有限，尽管持续饮酒，补充锌作为一种简单、低成本的干预措施，值得进行测试，以减轻艾滋病毒呈阳性者饮酒的后果。
