HIV Disease, Drug Abuse, & Nutrient Therapy in Botswana

描述（由申请人提供）：非洲博茨瓦纳是世界上艾滋病毒感染率最高的国家。此外，世界这一地区新出现的药物滥用问题可能会导致免疫抑制和营养状况下降，而这反过来又会促进艾滋病毒疾病的发展。这项应用是基于我们在非洲的研究表明，随着时间的推移，多种维生素补充剂显著增加了孕妇的CD4计数，我们在美国的研究表明，硒是艾滋病毒死亡率的有力预测因子，硒补充剂减缓了艾滋病毒疾病的进展。本申请的总体目标是确定补充多种维生素和硒是否可以改善博茨瓦纳艾滋病毒感染成人的免疫功能并延长艾滋病或死亡率的时间。我们将从博茨瓦纳筛查诊所招募828名参与者，这些诊所由合作的哈佛艾滋病研究所管理。CD4计数>350的受试者将被随机分配到4组析因设计中：多维生素与硒的组合，或单用多维生素，或单用硒，或安慰剂，持续24个月。该提议的具体目的是1）研究在改善免疫功能方面，多种维生素和硒的组合是否优于单独的多种维生素或单独的硒。2)研究补充多种维生素在改善免疫功能方面是否优于安慰剂。3)研究硒在改善免疫功能方面是否优于安慰剂。4)评估药物滥用如何影响HIV感染者的营养状况和HIV疾病进展。这项拟议的调查将确定营养疗法在博茨瓦纳改善免疫功能和减缓艾滋病毒疾病进展的有效性。由于非洲大多数国家的艾滋病病毒感染成人不易获得抗逆转录病毒治疗，因此这项研究可能提供一种延缓艾滋病病毒进展的替代方法。

DESCRIPTION (provided by applicant): The country of Botswana, Africa, has the highest rates of HIV infection in the world. Moreover, an emerging drug abuse problem in this part of the world may contribute to immune suppression and to the decline of nutritional status, which in turn facilitates HIV disease progression. This application is based on our African studies indicating that multivitamin supplementation significantly increased CD4 count in pregnant women over time, and our US studies showing that selenium is a powerful predictor of HIV mortality and that selenium supplementation slows HIV disease progression. The overall goal of this application is to determine whether supplementation with multivitamins and selenium can improve immune function and prolong time to AIDS or mortality in HIV infected adults in Botswana. We will recruit 828 participants from the Botswana screening clinics managed by the collaborating Harvard AIDS Institute. Participants with CD4 count >350 will be randomized into a factorial design with 4 groups: combination of multivitamins with selenium, or multivitamins alone, or selenium alone, or placebo, for 24 months. The specific aims of this proposal are 1) To investigate whether the combination of multivitamins and selenium is preferable to either multivitamins alone or selenium alone with respect to improving immune function. 2) To investigate whether multivitamin supplementation is preferable to placebo with respect to improving immune function. 3) To investigate whether selenium is preferable to placebo with respect to improving immune function. 4) To assess how drug abuse affects nutritional status and HIV disease progression in HIV infected men and women. This proposed investigation will determine the efficacy of nutrient therapy to improve immune function and slow HIV disease progression in Botswana. Since antiretroviral therapies are not readily available to HIV infected adults in most countries in Africa, this study may provide an alternative approach to retard HIV progression.