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This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.
The aim of the study is to compare the virological efficacy of the etravirine-based regimen with standard PI-containing regimen.
Etravirine is a second generation non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) approved by the U.S. Food and Drug Administration (FDA) in January 2008 and by the European Medicines Agency in September 2008 for clinical use in adults with incomplete virologic suppression and resistance to previous NNRTI and other antiretroviral classes.
A question that has not been explored is whether subjects with sustained undetectable HIV-1 RNA-levels experiencing antiretroviral-related toxicity can safely switch their current PI to etravirine. This treatment strategy could allow improvements in tolerability and lipid profile and would permit an easy posology (400 mg dissolved in water every 24 hours). We designed a proof-of-concept study to test the efficacy and safety of switching from a Protease Inhibitor (PI) to etravirine in subjects with viral suppression as an antiretroviral strategy of simplification therapy, based on the high antiviral potency, low toxicity, together with its easy posology (in water dissolution).
Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach.
The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Etravirine 400 mg dissolved in water every 24 hours, Continue with the same regimen
Germans Trias i Pujol University Hospital
Germans Trias i Pujol Hospital
Published on BioPortfolio: 2014-08-27T03:17:11-0400
The primary objective is to continue the provision of etravirine (ETR) for patients who previously received ETR in a clinical pediatric trial sponsored by or in collaboration with Tibotec,...
This study aims to provide information about the safety and pharmacokinetic drug-drug interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in HIV-infected pat...
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The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.
The HIV-1 reverse transcriptase (RT) natural polymorphism E138A is included among the mutations with a minor impact on response to etravirine. However, the interpretation of E138A on etravirine suscep...
The characteristics of nitrous oxide, NO, from a sewage treatment plant, which conducts nitrogen removal, and the river that receives its effluent water, were investigated by intensive daily surveys i...
Simultaneous suppression of rice ( L.) uptake of As and Cd is challenging because these toxic elements are immobilized under contrasting redox conditions. Given the notion that oxygen diffusion govern...
In literature it is stated that the stability of oil-in-water emulsions could be enhanced by decreasing the so-called "hydrophobic interactions" between surfaces through removal of dissolved atmospher...
Distinguishing the Properties and Sources of the Dissolved Organic Matter in Karst Reservoir Water During Winter Using Three-Dimensional Fluorescence Spectrum Technology:A Case Study in Wulixia Reservoir of Guangxi Province.
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Chemical compounds which yield hydrogen ions or protons when dissolved in water, whose hydrogen can be replaced by metals or basic radicals, or which react with bases to form salts and water (neutralization). An extension of the term includes substances dissolved in media other than water. (Grant & Hackh's Chemical Dictionary, 5th ed)
A condition of the feet produced by prolonged exposure of the feet to water. Exposure for 48 hours or more to warm water causes tropical immersion foot or warm-water immersion foot common in Vietnam where troops were exposed to prolonged or repeated wading in paddy fields or streams. Trench foot results from prolonged exposure to cold, without actual freezing. It was common in trench warfare during World War I, when soldiers stood, sometimes for hours, in trenches with a few inches of cold water in them. (Andrews' Diseases of the Skin, 8th ed, p27)
Water from natural sources which contain significant concentrations of dissolved salts such as sodium chloride.
Medicated dosage forms for topical application in the vagina. A cream is a semisolid emulsion containing suspended or dissolved medication; a foam is a dispersion of a gas in a medicated liquid resulting in a light, frothy mass; a jelly is a colloidal semisolid mass of a water soluble medicated material, usually translucent.
The flow of water in enviromental bodies of water such as rivers, oceans, water supplies, aquariums, etc. It includes currents, tides, and waves.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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