Macronutrient Supplement for HIV-Infected Patients Initiating ART
Principal Investigator:
- Wafaa El-Sadr, M.D., M.P.H., Mailman School of Public Health, Columbia University
Co-Investigators:
- Stephen Arpadi, M.D., M.S., Columbia University
- Richard Deckelbaum, M.D., Columbia University
- Mark Hawken, M.D., M.S., Mailman School of Public Health, Columbia University
- Pricilla Nyakundi, M.B., M.Med. Ped., M.Sc., Kenya Medical Research Institute
Abstract
While the advent of effective antiretroviral therapy (ART) in resource limited settings holds promise of making a substantial impact on health and well-being, many HIV-infected persons suffer from lack of nutrition and develop weight loss and wasting, often with severe consequences including death. Background malnutrition in sub-Saharan Africa is very important in HIV given that over 30% of people have insufficient food intake and decrease in weight as measured by decrease in body mass index (BMI) to less than 18 is strongly predictive of death. Even with use of ART, weight loss during first 4 weeks of ART is also associated with death. Most studies to date have paid little attention to utilization of food (macronutrient) as a major tool for nutrition intervention. Thus, national guidelines, while acknowledging the importance of the patients’ nutritional status, do not provide specific recommendations due to the lack of rigorous evidence.
We propose a study to determine whether HIV-infected patients with BMI <18.5 who are initiating ART and multiple micronutrient supplements (MMS) as per national guidelines will have improved nutritional, clinical, immunologic outcomes as well as improvement in performance status and quality of life measures with specific food supplementation. The study will be conducted at two health facilities in Central Province in Kenya. One site will receive ART, the food supplement and MMS while the other will receive standard of care (ART play MMS). The primary outcome will be change in BMI from baseline to 12 months i.e. 6 months after completion of nutrition supplementation to determine durability of any effect. Secondary outcomes will include change in measures of body composition, mortality, clinical outcomes, CD4 cell count, performance status, quality of life and changes in nutritional blood parameters.
There is an urgent need to define the influence of nutritional status on patient outcomes in the context of use of ART in resource-limited settings. Findings from the proposed study can have a substantial impact on the management of individual patients and can serve to guide national policy.