Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial.
Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-12-192
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发表时间：
2011-08-13
期刊：
影响因子：
2.5
通讯作者：
Warren D
中科院分区：
文献类型：
--
作者：
Kamwesiga J;Mutabazi V;Kayumba J;Tayari JC;Smyth R;Fay H;Umurerwa A;Baziruwiha M;Ntizimira C;Murebwayire A;Haguma JP;Nyiransabimana J;Habarurema D;Mukarukundo V;Nzabandora JB;Nzamwita P;Mukazayire E;Mills EJ;Seely D;McCready DJ;Warren D
血清硒水平低与东非HIV+患者死亡风险增加有关。我们的目的是评估补充硒对卢旺达HIV感染患者的CD 4细胞计数、HIV病毒载量、机会性感染和生活质量的影响。将在卢旺达的两个地点进行一项为期24个月、多中心、患者和提供者设盲、随机、安慰剂对照的临床试验，涉及300名接受抗逆转录病毒治疗（ART）前的艾滋病毒感染者。将招募年龄≥ 21岁、有记录的HIV感染、CD 4细胞计数为400-650个细胞/mm 3且尚未接受ART治疗的患者。患者将在每个研究中心使用随机区组设计随机接受硒微量营养素补充剂或每天服用一次的相同外观的安慰剂。主要结局是从基线到CD 4 T淋巴细胞计数降至350个细胞/mm 3以下（至少间隔一周通过两次测量确认）或开始ART或出现记录在案的CDC定义的AIDS定义疾病的时间的复合。将使用逐步回归和结构方程模型进行意向治疗分析。旨在提高CD 4细胞计数、减少机会性感染、降低艾滋病毒载量并最终推迟启动更昂贵的抗逆转录病毒治疗的营养干预措施可能是有益的，特别是在资源有限的环境中，如撒哈拉以南非洲。需要进行更多的试验来确定微量补充剂是否可以推迟艾滋病毒感染者对更昂贵的ART的需求。如果硒补充剂被证明是有效的，它可能对艾滋病毒感染人群具有公共卫生重要性，特别是在撒哈拉以南非洲和其他资源有限的环境中。NCT01327755
Low levels of serum selenium are associated with increased risk of mortality among HIV+ patients in East Africa. We aim to assess the effect of selenium supplementation on CD4 cell count, HIV viral load, opportunistic infections, and quality of life in HIV-infected patients in Rwanda. A 24-month, multi-centre, patient and provider-blinded, randomized, placebo-controlled clinical trial involving 300 pre-antiretroviral therapy (ART) HIV-infected patients will be carried out at two sites in Rwanda. Patients ≥ 21 years of age with documented HIV infection, CD4 cell count of 400-650 cells/mm3, and not yet on ART will be recruited. Patients will be randomized at each study site using a randomized block design to receive either the selenium micronutrient supplement or an identically appearing placebo taken once daily. The primary outcome is a composite of time from baseline to reduction of CD4 T lymphocyte count below 350 cells/mm3 (confirmed by two measures at least one week apart), or start of ART, or the emergence of a documented CDC-defined AIDS-defining illness. An intention-to-treat analysis will be conducted using stepwise regression and structural equation modeling. Micronutrient interventions that aim to improve CD4 cell count, decrease opportunistic infections, decrease HIV viral load, and ultimately delay initiation of more costly ART may be beneficial, particularly in resource-constrained settings, such as sub-Saharan Africa. Additional trials are needed to determine if micro-supplementation can delay the need for more costly ART among HIV-infected patients. If shown to be effective, selenium supplementation may be of public health importance to HIV-infected populations, particularly in sub-Saharan Africa and other resource-constrained settings. NCT01327755
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影响因子：
3.8
作者：
BAUM, MK;SHORPOSNER, G;HENNEKENS, CH
通讯作者：
HENNEKENS, CH
DOI：
10.1097/00042560-199904150-00015
发表时间：
1999-04-15
期刊：
JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
影响因子：
--
作者：
Campa, A;Shor-Posner, G;Baum, MK
通讯作者：
Baum, MK
影响因子：
105.7
作者：
Montori, VM;Permanyer-Miralda, G;Guyatt, GH
通讯作者：
Guyatt, GH
在系统评价的时代，单个试验的规模仍然很重要。
影响因子：
15.8
作者：
Guyatt, Gordon H.;Mills, Edward J.;Elbourne, Diana
通讯作者：
Elbourne, Diana
DOI：
10.1097/00042560-199708150-00007
发表时间：
1997-08-15
期刊：
JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
影响因子：
--
作者：
Baum, MK;ShorPosner, G;Page, JB
通讯作者：
Page, JB