TRIAL COMPARING TWO STRATEGIES FOR MANAGEMENT OF ANTIRETROVIRAL THERAPY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The SMART study is being done because, although anti-HIV/AIDS drugs are available, healthcare providers still have questions about the best ways to use these drugs to treat people living with HIV. Many healthcare providers now treat patients with daily drugs in order to keep the amount of virus in the blood (viral load) as low as possible. We know that this approach to using anti-HIV drugs is very effective in helping people with CD4 counts less than 200-250 cells live longer without serious diseases. But we do not know if this is the best way to use anti-HIV drugs to treat HIV disease in patients with higher CD4 counts over many years. There is information suggesting that patients may be able to wait to use anti-HIV drugs because the risk of getting sick appears low while CD4 counts are higher than 250 cells. We are not sure if waiting to use anti-HIV drugs is better than using anti-HIV drugs at higher CD4 counts. Most information used to guide healthcare providers and patients about the treatment of HIV disease comes from different types of studies that were carried out over a short period of time. A new kind of study that is carried out over several years is needed. To help healthcare providers and patients decide how to use anti-HIV treatments over many years, the SMART study will compare two ways of using anti-HIV drugs in a large number of HIV-infected people and follow them over a long period of time. Implementation of antiretroviral treatment guidelines, which emphasize maximal and durable suppression of viral load for the majority of individuals infected with HIV, has resulted in a substantial decline in morbidity and mortality. However, many asymptomatic patients are not at immediate risk of serious opportunistic diseases, the effectiveness of antiretroviral therapy wanes over time due to HIV drug resistance, and there are both short- and long-term toxicities of treatment. This motivates a comparison of two strategies, one which conserves treatments by deferring their use while the risk of opportunistic disease is low and one which aims for sustained virologic suppression irrespective of disease risk.