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.
