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Nutrition and HIV Progression

$356,027R01FY2009HDNIH

Tufts University Boston, Boston MA

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): There are more than 40 million individuals infected with HIV living throughout the world, the majority of these live within the resource-limited world. It has been clear throughout the HIV epidemic that the nutritional status of the host plays an important, independent role in HIV-associated outcomes particularly progression of HIV disease and mortality. Although it would appear to be intuitive that maintenance of or improvement in nutritional status would lead to improved outcomes in HIV infected individuals, few data are available to demonstrate the potential benefits of maintaining nutrition status at normal. There are data that suggest that the use of micronutrients could reduce CD4 count decline and delay death, however micronutrients alone will not support or maintain nutritional status. The overall hypothesis of this application is that the consumption of a nutrient dense protein supplement (NDPS) early in HIV infection will slow disease progression, and that the time from infection with HIV to the initiation of HAART will be prolonged. If this hypothesis is proven to be correct, this type of intervention will result in benefit to the individual, as the need for the use of HAART would be delayed. It would also benefit the health systems, as cost savings would result from a delay in the initiation of HAART. Specifically we propose to enroll 740 HIV infected women in Kenya, with CD4 counts between 350 cells/<L and 500 cells/<Land no symptoms, opportunistic infections or AIDS defining illnesses or malnutrition (BMI <18.5 kg/m2) that would require the initiation of HAART. These individuals with early disease will be randomized to a group that will be provided with the nutrient dense protein supplement (NDPS) or standard of care (SOC) and followed until the initiation of HAART is necessary or a total of 2 years. Outcomes in this study will include the need for the initiation of HAART, the rate of decline of CD4 cell count, overall nutritional status as measured by BMI and lean body mass, and quality of life. We will determine the cost effectiveness of this intervention strategy. In order determine if the dietary intake and the nutritional status (BMI) of the HIV-infected women with early disease is within the community norm, we need to evaluate the dietary intake and nutritional status of similar but non HIV-infected women in the local community. We propose to collect data on 200 women who are documented to be HIV-negative from Voi Division at a single visit, the Division that will also provide the HIV -infected women for the intervention study.

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