ABSTRACT
In a phase I/IIa clinical trial, 17 HIV-1 infected patients, stable on cART, received 4 vaccinations with autologous dendritic cells electroporated with mRNA encoding Tat, Rev and Nef, after which cART was interrupted. Vaccination was safe and feasible. During the analytical treatment interruption (ATI), no serious adverse events were observed. Ninety-six weeks following ATI, 6/17 patients remained off therapy. Although induced and/or enhanced CD4(+) and CD8(+) T-cell responses specific for the immunogens were observed in most of the patients, we found no correlation with the number of weeks off cART. Moreover, CD4(+) T-cell counts, plasma viral load and the time remaining off cART following ATI did not differ from historical control data. To conclude, the vaccine was safe, well tolerated and resulted in vaccine-specific immune responses. Since no correlation with clinical parameters could be found, these results warrant further research in order to optimize the efficacy of vaccine-induced T-cell responses.
Subject(s)
AIDS Vaccines/immunology , Dendritic Cells/immunology , HIV Infections/therapy , HIV-1/immunology , Immunization , Adult , Aged , Cells, Cultured , Gene Products, rev/immunology , Gene Products, tat/immunology , HIV Infections/immunology , Humans , Male , Middle Aged , nef Gene Products, Human Immunodeficiency Virus/immunologyABSTRACT
BACKGROUND: Guideline implementation programs for patients with acute myocardial infarction (AMI) enhance adherence to evidence-based medicine (EBM) and improve clinical outcome. Although undertreatment of patients with AMI is well recognized in both acute and chronic phases of care, most implementation programs focus on acute and secondary prevention strategies during the index hospitalization phase only. HYPOTHESIS: Implementation of an all-phase integrated AMI care program maximizes EBM in daily practice and improves the care for patients with AMI. AIM: The objective of this study is to assess the effects of the MISSION! program on adherence to EBM for patients with AMI by the use of performance indicators. DESIGN: The MISSION! protocol is based on the most recent American College of Cardiology/American Heart Association and European Society of Cardiology guidelines for patients with AMI. It contains a prehospital, inhospital, and outpatient clinical framework for decision making and treatment, up to 1 year after the index event. MISSION! concentrates on rapid AMI diagnosis and early reperfusion, followed by active lifestyle improvement and structured medical therapy. Because MISSION! covers both acute and chronic AMI phase, this design implies an intensive multidisciplinary collaboration among all regional health care providers. CONCLUSION: Continuum of care for patients with AMI is warranted to take full advantage of EBM in day-to-day practice. This manuscript describes the rationale, design, and preliminary results of MISSION!, an all-phase integrated AMI care program.
