Comparison of standard and immune-enhancing oral formulas in asymptomatic HIV-infected persons: a multicenter randomized controlled clinical trial

BACKGROUND: Both standard and immune-enhancing oral formulas are widely used to forestall HIV wasting and to promote immune function. However, there is little scientific evidence to support the differential effects of these formulas in asymptomatic HIV disease. The aim of this study was to compare the effects of an immune-enhancing oral formula and a standard oral formula on nutrition and immune measures in asymptomatic HIV-infected persons. A secondary aim was to evaluate the feasibility of maintaining a diverse sample of outpatients on a long-term oral formula protocol. METHODS: In this multicenter controlled nonblinded study, 90 asymptomatic HIV-infected persons with CD4 cell counts between 275 and 550 cells/mm3 were randomized to a control group; a standard oral formula group (Ensure Plus); or an immune-enhancing oral formula group (Advera). All groups received basic nutrition counseling. Participants were evaluated on nutrition, immune, and feasibility measures at 3-month intervals during the 12-month study period. Differences in nutrition and immune measures among the 3 groups were analyzed using the Kruskal-Wallis and Wilcoxon tests. Wilcoxon tests and correlation coefficients were used to analyze feasibility data. RESULTS: Sixty-six outpatients completed the 12-month study protocol. Among the 3 groups, there were no significant differences with respect to body weight, bioelectrical impedance analysis (BIA)-derived body cell and fat mass, daily caloric intake, and serum albumin at any of the study visits. Moreover, absolute CD4+ T lymphocytes and percentages did not significantly differ at any time point among the 3 groups. Acceptability and tolerance of the formulas were high for both the standard and immune-enhancing oral formula groups. CONCLUSIONS: Within the context and limitations of this study, standard and immune-enhancing oral formulas consumed daily for 1 year had no differential effects on nutrition or immune parameters in asymptomatic HIV-infected persons. While feasible and well-tolerated, a 1-year course of standard and immune-enhancing oral formulas resulted in no differential effects on nutrition or immune-status parameters in a diverse sample of asymptomatic HIV-infected persons.