The major new clinical trial aims to determine whether the HIV-seropositive asymptomatic have less risk of developing AIDS or other serious illnesses if they started taking antiretroviral drugs earlier, or later, based on their level of T CD4 + lymphocytes. An HIV-infected individual and the level of CD4 + T cells and commonly referred to as a CD4 count, which is a key measure of the immune system. The study is co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health USA.
While data from randomized clinical trials exist to support antiretroviral treatment CD4 counts fall below 350 cells per cubic millimeter (mm³), well-designed clinical studies have not been done to guide support decisions to start treatment above that threshold . Consequently, the orientations are different with regard to if and when to initiate antiretroviral therapy in asymptomatic HIV-infected persons with CD4 counts above 350 cells / mm³. Current guidelines US recommend that these individuals should begin antiretrovirals when their CD4 count falls below 500 cells / mm³, whereas the World Health Organization recommends this group start treatment only when their CD4 cell count falls to or below 350 cells / mm³ alone, ie regardless of viral load.
Phase IV of the study, known as the trial of the strategic distribution antiretroviral treatment (This is a free translation Strategic Timing of Antiretroviral Treatment, generating the acronym that gives its name to the study: START), It is a randomized clinical trial designed to provide evidence of the risks and benefits of early antiretroviral treatment to more clearly define the ideal time to begin administering the medication. It is intended to determine whether antiretroviral therapy immediately among HIV-infected individuals with CD4 levels above 500 cells / mm³ is better than delaying treatment until CD4 counts fall below 350 in terms of potential benefits and risks, such as AIDS development (Acquired Immunodeficiency Syndrome) and other serious diseases, including cardiovascular disease, cancer, kidney failure and liver disease, or death. The launch of the START study follows the successful completion of a pilot study involving more than 1.000 participants.
"Some epidemiological evidence suggests that HIV-infected patients remain healthier when starting treatment in high counts of CD4. However, there are also concerns about the health complications and side effects associated with use of antiretroviral lifelong and the possibility that the virus will become resistant to drugs, "says the director of NIAID Anthony SS Fauci, MD" The starting point of the study will provide a clearer answer as to the best time to start treatment for d those with HIV, taking into account both the risks and benefits associated with early versus delayed treatment. "
START will be held in 30 countries. It will enroll 4.000 men and women infected with HIV 18 years of age and older whose CD4 counts are above 500 cells / mm³ and who have never taken antiretroviral therapy. Once you enter the study, half of the participants will be randomly chosen to receive immediate antiretroviral treatment. The other half of the study group will not receive antiretroviral treatment until CD4 counts fall below 350 cells / mm³ or events related to AIDS occur.
This clinical study will select the appropriate antiretroviral regimen for each participant in a pre-approved based on the US Department of Health and Human dosServiços in the treatment guidelines list. The HIV-medicamentosanti that are being used in the study are already approved drugs for the treatment and will be donated by Abbott Laboratories, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck & Co. and Tibotec Pharmaceuticals.
Participants will be followed for up to five years. Once registered, they will return to the clinic to be seen by study personnel after a month, after four months and then every four months. At each visit, participants will provide a medical update and will undergo a brief medical examination and counting cells CD4 and quantification of viral load (amount of HIV virus in the blood), which will be recorded. The study is being conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), HIV / AIDS clinical study funded by the NIAID network. The University of Minnesota in Minneapolis is the lead sponsor of the study, along with NIAID and the funding of supplemental funds provided by other NIH entities, including the National Cancer Institute, the National Heart, Lung and Blood Institute, National Institute Mental Health, National Institute of Neurological Disorders and Stroke, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Additional support comes from four government organizations based in Australia, France, Germany and the United Kingdom.
Although START, first, throw a look for great results in health associated with immediate and delayed initiation of antiretroviral therapy, the study will also examine the transmission of HIV and risk behavior, treatment adherence, drug resistance, health care, the use and cost of health care. "The intention is to fully assess the individual and the general public as well as the health implications existing prior to antiretroviral treatment," said James D. Neaton, Ph.D., University of Minnesota, principal investigator of INSIGHT.
START will also possess several sub-studies to be conducted in some of 200 study sites. These include sub-studies examining the effects of genetic variants of the virus on the untreated HIV progression as well as the patient's response to antiretroviral therapy, comparing the beginning and deferred antiretroviral therapy groups, cognitive function and measures vascular function, Pulmonary function, and bone mineral density and assess the understanding of the participants on the information about the study and satisfaction with the consent process to better inform future investigação.START guidelines is identified ashttp://www.clinicaltrials.govNCT00867048. VisitNIAID HIV / AIDS Web Portalfor more information about NIAID, HIV / AIDS research.
NIAID conducts and supports research and NIH, throughout the United States, and all over the world to study the causes of the infection and immune mediated diseases, and to develop better means of preventing, diagnosing and treating these diseases. News releases, newsletters and other related materials are available on the NIAID.NIAID website
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Translated by Claudio de Souza Santos the Otiginal in NIH Study Examines Best Time for Healthy HIV-infected People to Begin Antiretrovirals and it was revised by Mara Macedo. The text is original 2011 and was inserted into the site for document consistency issues for our users to have an overview of the study in 13 July 2015. We apologies for our initial failure to report on time and in proper time.