Massage Benefits in HIV+ Children: Mechanisms of Action

描述(申请人提供)：尽管努力控制艾滋病毒感染的传播，但全世界仍有超过320万儿童感染艾滋病毒/艾滋病，560万儿童死于这种毁灭性的疾病。在多米尼加共和国等发展中国家，抗逆转录病毒药物尚不能轻易用于减缓疾病进展。即使获得治疗，仍然没有治愈方法，副作用可能很严重，而且很难坚持，特别是在可能需要终生坚持的情况下。此外，抗逆转录病毒治疗的免疫恢复的完整性和程度因个体而异。因此，免疫恢复仍然是首要任务，确定在改善临床症状的同时不需要额外药物的治疗方式至关重要。我们的R21 NCCAM赠款的初步研究结果表明，按摩疗法对无法获得抗逆转录病毒药物的艾滋病毒多米尼加儿童的疾病进展标志(T淋巴细胞数量)有显著影响，并可能改变艾滋病毒的病程。为了支持这一概念，在艾滋病毒青少年和成年人进行推拿治疗后，已证明免疫能力增强。这项拟议研究的双重目的是扩展我们的初步发现，在更大的样本量(80vs27)和更大的年龄范围(2-12岁vs2-8岁)的HIV儿童中评估推拿疗法对免疫恢复的影响，并探讨推拿作用的潜在神经免疫机制。为了实现这些目标，我们提议对80名艾滋病多米尼加儿童进行临床试验，随机接受按摩，每周两次-持续12周(n=40组1)或不按摩治疗(n=40组2)。第二组随后将接受按摩干预，这可能允许确认按摩诱导的免疫反应。第一组在按摩后3个月进行随访，以评估效果的持久性。将收集数据以评估按摩对免疫恢复(CD4、CDS、PHA、IL-2)、应激水平(皮质醇)和促炎细胞因子(IL-6、TNF-α)的影响。将检查疾病状态、抗逆转录病毒治疗和病毒负担，并在分析中考虑它们作为协变量的潜在效用。长期目标是为可行的CAM疗法建立严格的科学证据，该疗法有助于减轻免疫系统受损患者的疾病负担。

DESCRIPTION (provided by applicant): Despite great efforts to control the spread of HIV infection, more than 3.2 million children are living with HIV/AIDS worldwide, and 5.6 million children have died from this devastating disease. In developing countries, such as the Dominican Republic, antiretroviral medications are not yet readily available to slow disease progression. Even with access to treatment there still is no cure, side effects can be severe, and adherence is difficult, especially when it may have to be life-long. Moreover, the completeness and degree to which immune recovery occurs with antiretroviral therapy, varies among individuals. Thus, immune restoration remains a foremost priority, and identifying treatment modalities that do not require additional medications while improving clinical symptoms are of critical importance. Preliminary findings from our R21 NCCAM grant, indicate that massage therapy has a significant impact on markers of disease progression (T lymphocyte numbers) in HIV+ Dominican children without access to antiretrovirals, and may have the potential to alter the course of HIV disease. In support of this concept, increased immune capacity has been demonstrated following massage therapy in HIV+ adolescents and adults. The two-fold intent of the proposed research is to extend our preliminary findings to evaluate the impact of massage therapy on immune recovery in a larger sample size (80 vs 27) and greater age range (2-12 yrs vs 2-8 yrs) of children with HIV, and to investigate a potential neuroimmune mechanism of massage action. To achieve these goals, we are proposing a clinical trial with 80 HIV+ Dominican children randomized to receive massage, twice weekly-for 12 weeks (n=40 Group 1) or no massage treatment (n=40 Group 2). Group 2 will subsequently receive the massage intervention, which may allow confirmation of the massage-induced immune response. Group 1 will be followed at 3 months post massage to evaluate durability of the effect. Data will be gathered to assess the impact of massage on immune recovery (CD4, CDS, PHA, IL-2), stress levels (cortisol) and proinflammatory cytokines (IL-6, TNF-alpha). Disease status, antiretroviral therapy, and viral burden, will be examined and their potential utility as covariates in the analyses considered. The long-term objective is to establish rigorous scientific evidence for a feasible CAM therapy that can contribute to reducing the burden of disease for those living with compromised immune systems.