Massage Benefits in HIV+ Children: Mechanisms of Action

描述（申请人提供）：尽管为控制艾滋病毒感染的传播做出了巨大努力，但全世界仍有超过 320 万儿童感染艾滋病毒/艾滋病，并且有 560 万儿童死于这种毁灭性疾病。在多米尼加共和国等发展中国家，尚无法轻易获得抗逆转录病毒药物来减缓疾病进展。即使获得治疗，仍然无法治愈，副作用可能很严重，而且坚持很困难，尤其是当它可能必须是终生的时候。此外，抗逆转录病毒治疗免疫恢复的完整性和程度因人而异。因此，免疫恢复仍然是首要任务，确定不需要额外药物同时改善临床症状的治疗方式至关重要。我们的 R21 NCCAM 拨款的初步结果表明，按摩疗法对无法获得抗逆转录病毒药物的多米尼加艾滋病毒儿童的疾病进展标志物（T 淋巴细胞数量）具有显着影响，并且可能有可能改变艾滋病毒疾病的进程。为了支持这一概念，艾滋病毒青少年和成人接受按摩治疗后的免疫能力得到了增强。拟议研究的双重目的是扩展我们的初步研究结果，以更大的样本量（80 岁与 27 岁）和更大的年龄范围（2-12 岁与 2-8 岁）的 HIV 儿童中评估按摩疗法对免疫恢复的影响，并研究按摩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 HIV 多米尼加儿童进行一项临床试验，他们随机接受按摩治疗，每周两次，持续 12 周（n = 40 第 1 组）或不接受按摩治疗（n = 40 第 2 组）。第 2 组随后将接受按摩干预，这可以确认按摩引起的免疫反应。第 1 组将在按摩后 3 个月进行随访，以评估效果的持久性。将收集数据来评估按摩对免疫恢复（CD4、CDS、PHA、IL-2）、压力水平（皮质醇）和促炎细胞因子（IL-6、TNF-α）的影响。将检查疾病状况、抗逆转录病毒治疗和病毒负荷，并考虑它们作为协变量的潜在用途。长期目标是为可行的 CAM 疗法建立严格的科学证据，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.