TICIPS: HIV/AIDS, Secondary Infections and Immune Modulation

描述（由申请人提供）：估计有469万南非人感染了1型人类免疫缺陷病毒（HIV）。艾滋病毒感染是无法治愈的，如果不治疗，大约95%的感染者最终是致命的。L frutescens被认为是非洲南部传统医学中最有效的植物之一。这种植物已经在当地被用来治疗严重的微生物感染，特别是HIV感染，以及癌症和炎症。有益的效果也被观察到在浪费条件和压力相关的疾病。它可能对艾滋病毒感染的成年人有有益的影响。根据医疗成果研究艾滋病毒健康调查（MOS-HIV）工具，早期艾滋病毒感染与多种族南非人的生活质量显著下降有关。观察到的frutescens的抗炎特性可能有利于影响细胞因子网络，从而对生活质量、病毒复制和免疫功能产生有益影响。重要的是要证明这种广泛使用的植物疗法可以安全地用于艾滋病毒感染的成年人，并试图证明潜在的有益影响。最近的数据表明，Sutherlandia与通常用于治疗艾滋病毒感染的抗逆转录病毒药物之间存在显著的体外相互作用。我们提出了一项为期4年的随机安慰剂对照试验，以确定该植物的安全性及其对生活质量和HIV疾病进展标志物的影响。

DESCRIPTION (provided by applicant): An estimated 4.69 million South Africans are infected with Type 1 human immunodeficiency virus (HIV). HIV infection in incurable and, if untreated, is ultimately fatal in approximately 95% of infected individuals. L frutescens is thought to be among the most efficacious plants used in southern African traditional medicine. The plant has been used in indigenous settings to treat serious microbial infections, especially HIV infection, as well as cancer and inflammatory conditions. Beneficial effects have also been observed in wasting conditions and stress-related disorders. It is possible that L frutescens may have useful effects in HIV infected adults. Early HIV infection has been associated with a significant reduction in quality of life in multiracial South Africans measured by the Medical Outcomes Study HIV Health Survey (MOS-HIV) instrument. The observed anti-inflammatory properties of L. frutescens may favourably influence cytokine networks with beneficial effects on quality of life, viral replication and immune functioning. It is essential to document that this widely used phytotherapy can be used safely in HIV-infected adults, and to attempt to demonstrate potentially beneficial affects. Recent data has demonstrated that there are significant in vitro interactions between Sutherlandia and antiretrovirals commonly used to treat HIV infection. We propose a 4- year randomized placebo controlled trial of Lesssertia frutescens in order to determine this plant species safety and effects on quality of life and markers of HIV disease progression. Specific Aim 1: To determine the safety of Lessertia frutescens used by HIV-1 infected adults. Specific Aim 2: To determine the effect of Lessertia frutescens on quality of life in HIV-infected adults measured by the Medical Outcomes Study HIV Health Survey (MOS-HIV). Specific Aim 3: To assess the influence of Lessertia frutescens on CD4 T-lymphocyte count in HIVinfected adults. Specific Aim 4: To evaluate the impact of Lessertia frutescens on HIV viral load in HIV-infected adults.