Micronutrient supplementation to prevent disease progression in HIV infected adults in Botswana
M. Baum1, A. Campa1, S. Lai2, S. Sales1, Y. Li1, P. Burns3, H. Bussmann4, S. Moyo4, E. Widenfelt4, I. Thior5, L. Tsalaile4, J. Makhema4, W. Fawzi3, M. Essex3, R. Marlink3, Dikotlana Study Team
1Florida International University, R Stempel College of Public Health and Social Work, Miami, United States, 2Johns Hopkins University, Bloomberg School of Health, Baltimore, United States, 3Harvard University, Harvard School of Public Health, Boston, United States, 4Botswana Harvard AIDS Institute, Gaborone, Botswana, 5PATH, Washington DC, United States
Background: Botswana has one of the highest rates of HIV infection in the world. The objective of this trial was to determine whether supplementation with micronutrients can improve immune function and prolong time to AIDS in HIV- infected adults in Botswana.
Methods: A prospective randomized controlled clinical trial was conducted with 875 HIV+ adults, who were not on antiretroviral therapy (ART) and had CD4+ count >350 cell/mm3, were randomly assigned into supplementation and placebo groups for 24 months. Supplementation included B-complex, Vitamins C and E, and Selenium. The micronutrient and placebo supplements had identical appearance. The primary endpoint was a drop of CD4+ count < 250 cells/mm3, which qualifies patients for ART in Botswana. CD4+ cell count was determined every 3 months and HIV-viral load every 6 months. Questionnaires, pill-counts, and plasma micronutrients were used to assess adherence with study supplements. Safety was determined with viral load, metabolic profiles and intercurrent events. Intent-to-treat analyses used CD4+ count < 250 cells/mm3 as endpoint for the Cox proportional-hazard models.
Results: Mean age of participants was 33.48±8.1 and 73% were women. Adherence with supplementation was 98%; compliance with study visits was 92%. Viral load, metabolic profiles and intercurrent events indicated the supplements were safe. Supplementation with micronutrients prolonged time to CD4+ count < 250 cells/mm3 compared to placebo, (HR=0.71, 95%CI:0.518, 0.979, p=0.0368).
Conclusion: This study demonstrated that long-term micronutrient supplementation was safe and significantly prolonged time to CD4+ count< 250 cells/mm3. This evidence supports the use of micronutrient supplementation as an effective intervention in HIV+ adults in early stages of the disease in Botswana. Analyses of the effect of supplementation on morbidity and mortality are now in progress. Nutritional supplementation prolongs the asymptomatic stage, improving patients' well-being, and may translate into financial savings and broader access to HIV treatment in developing countries.
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