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Press release
Thursday, May 9, 2019
The LATITUDE study compares monthly injectable antiretroviral therapy with daily oral medications.
A clinical trial to evaluate long-acting antiretroviral therapy for the maintenance of HIV suppression in people for whom adherence to conventional daily oral antiretroviral therapy was a challenge was initiated at sites research in the United States. This study, titled Long-Term Therapy to Improve Therapeutic Success in Everyday Life, or LATITUDE, will help determine whether a combination of two experimental formulations of injectable antiretroviral therapy is superior to conventional oral antiretroviral therapy for the management of HIV / AIDS. HIV infection in this population.
LATITUDE is funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. It is led by the AIDS Clinical Trials Group (ACTG), with additional support from the National Institute of Mental Health, National Institute for Addictions, ViiV Healthcare and the Janssen Pharmaceutical Companies from Johnson & Johnson.
"Antiretroviral therapy has transformed HIV treatment. Consistent medication as prescribed helps people live longer, healthier lives and prevent HIV transmission to sexual partners, "said Anthony S. Fauci, MD, NIAID Director. "Unfortunately, for many people who need to take any medication regularly, compliance can be difficult. Effective alternative formulations of antiretrovirals, including long-acting injectables, can help people better adapt to HIV treatment. "
LATITUDE (also known as ACTG 5359) will test two long-acting experimental injections of the antiretroviral drugs rilpivirine (RPV) and cabotégravir (CAB), which will be administered every 4 weeks by a healthcare professional in a clinic of research. Throughout the study, researchers will evaluate the viral load of volunteers (the measurement of the virus in the blood) and other indicators of immune health to compare the effectiveness of treatment with that of oral antiretroviral therapy. classic.
Almost a quarter of people on conventional antiretroviral therapy stop taking the drug for a while. Failure to take medication as prescribed is the most common reason why people can not permanently remove the virus. Many complex factors such as access to health care, economic and housing insecurity, and stigma can affect a person's ability to enroll in a treatment plan. Long-acting ART formulations can be particularly beneficial for those who can not or would not take medications daily or do not store oral medications at home or in their possession.
"A monthly injectable antiretroviral therapy might prove to be more convenient, unobtrusive, and appropriate for some people living with HIV," said Aadia Rana, MD, associate professor of medicine at the AIDS Research Center of the United States. University of Alabama in Birmingham and co-chair of the LATITUDE protocol. "Our study aims to help people living with HIV who face compliance problems to find a treatment option that meets their health needs and integrates into their lives, allowing them to benefit. health benefits of a lasting suppression of the virus.
LATITUDE will recruit about 350 volunteers whose treatments have been interrupted in the last 18 months. All study participants will start daily oral antiretroviral therapy and individualized support for adherence and retention. Volunteers whose virulence is suppressed at week 24 will then be randomized to continue standard treatment for one year or to begin oral treatment including a pest vaccine (PPV) and antico-respiratory therapy (CAB) for 4 weeks, followed by An injectable formulation of these long-acting drugs every 4 years. weeks for 48 weeks. After this 52-week period, participants initially randomized into the standard treatment group may switch to long-term treatment, and participants initially randomized to the long-acting therapy group may remain on this regimen for an additional year.
Like many other antiretroviral regimens, CAB and long-acting RPV will be administered in combination to prevent the development of viral resistance to a single drug. This treatment regimen is also under study in other clinical trials. Of these, the long-acting injectable CAB is currently being investigated as a means of preventing HIV in the NIAID-supported HPTN 083 and HPTN 084 studies. Since injectable CAB and RPV can remain in the body for several months, any participant who receives one or more doses of long-acting injectable medications and who needs or wants to stop these agents will be included in the safety follow-up for one month. additional year. . During this time, they will be prescribed standard antiretroviral therapy.
"Adhering to daily medications remains a major challenge for patients with chronic diseases," said Jose Castillo-Mancilla, MD, associate professor of medicine at the University of Colorado's Faculty of Medicine and co-chair of the LATITUDE protocol. "The generous volunteers who enroll in this study will help ensure that more people living with HIV can benefit from effective treatment that is right for them."
LATITUDE is supported by the grant NIAID UM1AI068636. For more information on the trial, please visit ClinicalTrials.gov under the study ID NCT03635788.
NIAID conducts and supports research – at NIH, in the United States, and around the world – to investigate the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose and treat these diseases. NIAID press releases, fact sheets and other documents are available on the NIAID website.
About the National Institutes of Health (NIH):
The NIH, the country's medical research agency, has 27 institutes and centers and is part of the US Department of Health and Human Services. NIH is the lead federal agency that leads and supports basic, clinical and translational medical research. She studies causes, treatments and cures for common and rare diseases. For more information on NIH and its programs, visit www.nih.gov.
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