HIV Vaccine Clinical Trials: The Standard of Care Debate

Human immunodeficiency virus type 1 (HIV-1) is a retrovirus infecting approximately 35.3 million people worldwide that leads to the development of acquired immunodeficiency syndrome (AIDS). HIV-1 selectively infects certain host immune cells, including CD4+ T cells, macrophages, and dendritic cells, resulting in the continual depletion of the host immune system (Global Report, 2013). More specifically, HIV-1 prevalence is concentrated in sub-Saharan Africa and other developing countries worldwide. In recent years, there has been much effort devoted to developing an effective vaccine against HIV-1. The vaccine clinical trials are typically held in these developing countries where HIV-1 prevalence is highest. The dilemma that continues to plague vaccine trials in developing countries pertains to the standard of care that should be provided to the participants who inevitably become infected with HIV-1 during the trial (Bloom, 1998). This standard of care debate revolved around topics such as what type of treatment should be provided to the participants, how long should the treatment continue, will treatment continue after the trial has concluded, who has the obligation to ensure the standard of care protocols are enforced, what are the repercussions in failing to do so, and most importantly, who is paying for all of this (Berkley, 2003). The Declaration of Helsinki clearly endorses the view that all trial participants are entitled to the worldwide best standard of care (Lie et al, 2004). Unfortunately, efforts to devise an accepted standard of care have continued without success since the 1990s (Berkley, 2003).

The root of the problem revolves around the expenses associated with treatment. This is an especially difficult ...

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