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HIV Trial Shows That Early Treatment of HIV Infection is Beneficial

March 30, 2017

A major international HIV clinical trial, the "Strategic Timing of AntiRetroviral Treatment”, or START study found that starting treatment early, at high CD4+ T-cell counts, reduces the risk of serious disease by half. The interim results were so compelling that an independent review board recommended that they be released a year ahead of schedule. The University of Minnesota contributed to the success of the study.

A press release from the NIH announced the study results. The announcement was groundbreaking, within hours it was featured on websites of many major newspapers, including The Wall Street Journal. The next day, the news was on the front page of the New York Times, featured on the PBS Newshour, as well as on news in Europe, Australia and South Africa

The global impact of HIV and AIDS is enormous. Millions of people all over the world are infected with HIV. Untreated, HIV slowly destroys the immune system, leading to death. There is no cure, but effective treatment is available.

Currently, it is hotly debated whether treatment should be started as soon as a person gets infected, or whether it is safe to wait, since it usually takes many years before symptoms develop. It was known that anti-HIV drugs substantially reduce the risk of transmitting HIV, but it was uncertain whether the individual patient would see any health benefit, or even might be harmed, while the immune system was still normal. START looked into whether giving the drugs early, at high CD4+ cell counts, even as soon as HIV was detected, would improve the patient’s outcome. The study was a huge international effort, conducted at 215 sites in 35 countries, by hundreds of investigators. The trial enrolled 4,685 HIV-infected men and women who, on average, were followed for three years. It was a stunning success; START showed that the starting treatment early benefits the individual along with the community.

The study was mainly funded by the NIH, but the administrative sponsor was the University of Minnesota, and we provided the statistical support. Biostatistics professor, Jim Neaton is the PI of the clinical trials network that conducted START, and Professor Birgit Grund of the University of Minnesota’s School of Statistics was part of the study’s statistics team.

We are excited to be part of an international collaboration like this, with its major benefits to the world.