A HIV study was stopped early after scientists and researchers realized that it would be unethical to continue the study for another year. The study which was designed to test the best way to distribute treatments to patients, was part of a clinical trial conducted internationally. This trial, known as Strategic Timing of AntiRetroviral Treatment (START), tracked approximately 4,600 individuals living with HIV in a number of countries starting in 2011.
The original goal of the trial was determine when it would be best to distribute antiretrovirals to those who had tested positive for HIV. By studying people receiving the combination of drugs designed to suppress the virus, researchers get a better idea of when is the best time to begin treatment. There were different groups of individuals, each set up to receive the antiretrovirals at different points of their infection. One group was set up to receive the cocktail of drugs as early as possible, while they were considered to still be relatively healthy. The second group would then receive the drugs after their white blood cell counts fell below a predetermined point.
Antiretrovirals have allowed many individuals living with HIV to live longer more healthy lives. Unfortunately, there are also some significant side effects associated with these drugs. These side effects have made many experts hesitant when prescribing treatments to patients. The worry seems to be that by giving antiretrovirals too soon, patients would be hurt more than they would be helped.
Originally START was set to conclude in 2016, but researchers chose to stop the HIV study early based on all of the already collected data and an overwhelming belief that it would be unethical to continue with what was already known. As with any study, participants were randomly assigned to groups, with each group getting treatment at different points.
As the trial continued, it became clear to the researchers that those individuals who received the treatment earlier were actually delivering drastically better results. Those individuals who were HIV-positive and received treatment early on had a reduced risk of not only developing a more serious illness, but also of dying by approximately 53 percent.
When the researchers took these results into account, they believed them to be so significant that they felt that it would be unethical to continue the study until the original end date in 2016. Instead, they have stopped the HIV study early and chosen to give all of the participants in the trial access to the antiretrovirals.
The director of the NIH’s National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, has said that with these findings it has become clear that it is significantly more beneficial health-wise for an HIV-positive individual to receive treatment as soon as possible. In an interview with NBC News, he said that this study actually has a significant impact on how treatment is dispersed on a global level.
Recently, the World Health Organization (WHO) had updated their guidelines for when treatment should be given for individuals who tested positive. In their guidelines, they say that treatments should be given as soon as possible, but with a stipulation that a patient’s white blood cell counts should be below a predetermined point.
Now, with the START study having stopped early because of significant results with early treatment of HIV-positive patients, it is possible that the international community will back treating every single person diagnosed, a stance that has already received support from the United Nations AIDS agency (UNAIDS). In fact, UNAIDS has clearly expressed their belief that every single person who is living with HIV should have access to the life saving antiretrovirals. Although the study may have ended early, it has delivered results that could save more lives in the future.
By Kimberley Spinney
Think Progress: New HIV Study Was So Dramatic, It Had To Be Stopped Early
Washington Post: Breakthrough HIV study could change course of treatment for millions
Yahoo News: NIH: Major study finds earlier HIV treatment improves health
Photo Courtesy of Michael Chen’s Flickr Page – Creative Commons License
Second Photo Courtesy of new1mproved’s Flickr Page – Creative Commons License