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An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens in Aged HIV Patients (RalAge)

Azienda Policlinico Umberto I · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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agedhivmedical-records
RAL is considered one of the better-tolerated antiretroviral medications, due to limited side effects and few long-term safety concerns. Five-year clinical trial outcomes and clinical experience have demonstrated durable virologic suppression in both treatment-naïve and treatment-experienced patients, including patients with extensive antiretroviral history and documented antiretroviral resistance. Studies have also exhibited low adverse effect rates and reliable long-term safety lending to improved tolerance. Several trials have evaluated the reduction in adverse effects in patients switched from various antiretroviral agents to RAL. Treatment-naïve studies have demonstrated a lipid-neutral effect in patients on RAL-containing regimens. When transitioning patients from a ritonavir-boosted PI regimen, statistically significant decreases in total plasma cholesterol, low-density lipoprotein, and triglycerides were demonstrated. Given its negligible interaction with the cytochrome P450 system, RAL displays minimal drug-drug interactions, making it a good option for ageing patients on multiple medications. This is an observational retrospective cohort in real world to describe RAL data, including NUC-sparing regimens, in aged HIV patients. It is a phase IV study. 90 patients will be enrolled from the Department of Public Health and Infectious Diseases of "Sapienza" University of Rome. More than 4000 HIV patients are followed at this Department of Public Health and Infectious Diseases of "Sapienza" University of Rome. More than 50% of these patients are ≥ 50 years. From 10 to 12% are treated with a raltegravir based- regimen. The primary endpoint will be the description of the proportion of participants with an HIV-1 viral load \< 50 copies/mL. The secondary endpoints will be: * Change from Baseline in CD4+ T-cell counts, CD8 cell counts, CD4/ CD8 ratio * Proportion of subjects with laboratory alterations * Proportion of patients with adverse events (AE), serious adv
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