The new major clinical trial aims to determine whether asymptomatic HIV-positive people are at a lower risk of developing AIDS or other serious diseases if they start taking antiretroviral drugs sooner or later based on their CD4 + T lymphocyte levels. An individual infected with HIV and the level of CD4 + T cells is commonly referred to as their 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), which is part of the US National Institutes of Health.
While data from randomized clinical trials exist to support antiretroviral treatment at CD4 counts drop below 350 cells per cubic millimeter (mm 3), well-designed clinical studies were not done to guide support decisions to initiate treatment above that threshold . As a consequence, the guidelines are different with regard to when and if to initiate antiretroviral treatment in asymptomatic patients infected with HIV people with CD4 counts above 350 cells / mm³. Current US guidelines recommend that these individuals should start antiretrovirals when their CD4 count drops below 500 cells / mm³, whereas the World Health Organization recommends this group start treatment only when their CD4 cell count drops 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 at high CD4 counts. However, there are also concerns about the health complications and side effects associated with lifelong antiretroviral use and the potential for the virus to become drug resistant, "says NIAID director Anthony SS Fauci, MD. starting point of the study will provide a clearer answer as to the best time to start treatment for HIV patients, taking into account both the risks and benefits associated with delayed onset versus treatment. "
START will be held in 30 countries. It will enroll 4.000 18 HIV-infected men and women aged 4 and older, whose CDXUMUMX counts are above 500 cells / mm³ and who have never taken antiretroviral therapy. As soon as they enter the study, half of the participants will be randomly selected to receive antiretroviral therapy immediately. The other half of the study group will not receive antiretroviral treatment until CDXUMUMX counts fall below 4 cells / mm³ or AIDS-related events occur.
This clinical study will select the appropriate antiretroviral regimen for each participant from a pre-approved list based on the US Department of Health and the guidelines for treatment of the Human Services. The anti-HIV drugs being used in the study are approved drugs for treatment and will be donated by Abbott Laboratories, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck & Co. and Tibotec Pharmaceuticals.
Participants will be followed up for up to five years. Once enrolled, they will return to the clinic to be seen by the study staff 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 cells CD4 and the quantification of the viral load (amount of HIV in the blood), which will be recorded.
O estudo está a ser realizado pela Rede Internacional para iniciativas estratégicas no Global HIV ensaios (INSIGHT), HIV/AIDS estudo clínico financiado pela rede NIAID. A Universidade de Minnesota em Minneapolis é o principal patrocinador do estudo, junto com o NIAID eo financiamento de verbas suplementares fornecidas por outras entidades ligadas ao NIH, incluindo o Instituto Nacional de Câncer, o Instituto nacional do coração, pulmão e sangue, o Instituto Nacional de Saúde Mental, do Instituto Nacional de distúrbios neurológicos e derrame, e do Instituto Nacional de artrite e doenças osteomusculares e de pele. Suporte adicional provém de quatro organizações governamentais com base na Austrália, França, Alemanha e Reino Unido.
Although START will first throw a look at major health outcomes associated with the immediate and delayed start of antiretroviral therapy, the study will also examine HIV transmission and risk behaviors, adherence to treatment, drug resistance, health care, use and cost of medical care. "The intent is to fully assess the individual and the general public, as well as the health implications of prior antiretroviral treatment," according to James D. Neaton, Ph.D., of the University of Minnesota, principal investigator at INSIGHT.
START will also have several sub-studies to be conducted at some of the 200 study sites. These sub-studies include examining the effects of genetic variants of the virus on untreated HIV progression, as well as the patient's response to antiretroviral therapy, comparing the onset and antiretroviral therapy groups deferred, cognitive function and measures of vascular function, Pulmonary function, and bone mineral density and will evaluate the participant's understanding of study information and satisfaction with the consent process to better inform future research guidelines. START is identified as http://www.clinicaltrials.gov NCT00867048. Visit the NIAID HIV / AIDS Web Portal for more information on The NIAID, HIV / AIDS research.
NIAID conducts and supports research and the NIH throughout the United States and in all parts of the world to study the causes of infectious disease and immune-mediated diseases as well as to develop better ways to prevent, diagnose and treat these diseases. News releases, newsletters and other materials related to NIAID are available at. NIAID website
About the National Institutes of Health (NIH): The NIH, the North American nation's medical research agency, includes 27 centers and institutes and is a component of the US Department of Health and Human Services. NIH Centers are the top federal agencies performing and supporting basic, clinical and translational AIDS research, and are investigating the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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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.