OBJECTIVES: Highly Active Anti-Retroviral Therapy (HAART) has significantly reduced HIV-related morbidity and mortality. Bartlett J et al. recently reviewed its efficacy in a clinical trial setting. The overall percentage of patients with HIV RNA=350/mm3, (d)a and c, and (e)b and c. Multivariate logistic regression models including demographics, regimen and baseline VL and CD4 count were constructed to identify significant predictors of these study outcomes. RESULTS: Analyses included 2776 subjects. Baseline characteristics were summarized (mean age 40, 88% male, 62% caucasian, 92% treatment naive, mean baseline VL 131,877, mean CD4 304). At week 24/switch, overall viral control was poor. For PI-HAART, the percentages of patients reaching outcomes (a)-(e) were 34, 30, 37, 18 and 16, respectively. For NNRTI-HAART: 33, 24, 53, 24 and 17, respectively. For NRTI-HAART: 20, 14, 42, 14 and 11, respectively. Multivariate analyses identified age, regimen, and baseline VL and CD4 count as significant predictors. CONCLUSIONS: Compared to clinical trial efficacy, real-world viral control rates are sub-optimal. More effective HIV therapy options appear to be needed to manage this unmet need and improve patient outcomes.