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CD4+ white blood cells are one of the body's natural infection fighters, but in HIV infection the number of these cells decreases over time, leading to illness and death. The use of triple-drug antiretroviral therapeutic regimens, also known as highly active antiretroviral therapy (HAART), has resulted in a decrease in the incidences of death and AIDS-defining illness for people with HIV infection. The duration of response to these antiretroviral regimens is often limited by the emergence of viral resistance or the development of toxicity, and there is increasing evidence from clinical practice that triple therapy fails a significant proportion of patients. Failure of successive regimens becomes increasingly likely due to mutational cross-resistance between drugs of the same class or decreased adherence caused by intolerance or increased complexity of the remaining effective regimens.
Previous studies have been carried out in an attempt to determine the "safe" amount of time for a period of treatment interruption. The purpose of OPTIMA is to find out if it is best to continue taking anti-HIV drugs without taking time off or if taking time off produces a better result.
Regulatory Information
The conduct of clinical trials is regulated by Health Canada, which has adopted the Good Clinical Practice guidelines developed by the International Committee of Harmonization.
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