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article imageDeception at the heart of African AIDS trial

By Tim Sandle     Feb 15, 2015 in Health
A failed clinical trial in Africa has raised questions about how to test H.I.V. drugs and has posed some serious issues relating to medical ethics.
There has been fallout following the failure of a large clinical trial of H.I.V. prevention methods trial in Africa. This is centered on an elaborate deception used by the women who took part in it. The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes the acquired immunodeficiency syndrome (AIDS).
According to The New York Times, as a result of the failed trial, scientists are arguing about the extent to which it is ethical to pay participants for their time, and whether results of trials that pay participants can be trusted.
Scientists who conduct clinical trials are now testing participants’ blood more often and holding group discussions to quell rumors and urge participants to take their medications diligently.
The trial was called VOICE, an acronym for Vaginal and Oral Interventions to Control the Epidemic. The trial was halted by independent safety monitors because it was clearly failing. With the trial, women were given pills or vaginal gels containing anti-H.I.V. drugs. However, despite the assumption that these afforded a level of safety, the women were becoming infected at the same rate as women who were given placebos.
Participants were randomized to use one of the following products daily:
tenofovir gel
placebo gel
oral tenofovir tablet
oral Truvada (the tenofovir/emtricitabine combination)
oral placebo pill
The ethical questions here are: is it right that women are given placebos when they face the risk of contracting a life-threatening virus? Furthermore, is it right that the women who were given the prophylactic medications were being given something that clearly was not safe?
The study, backed by the U.S. National Institutes of Health intended to establish whether pre-exposure prophylaxis would work for African women. The study enlisted 5,029 women at 15 clinics in South Africa, Zimbabwe and Uganda.
Because all blood samples were stored for up to a year after being sampled, the scientists had no clear idea whether the gels were working or not. The charge against the study is that it was irresponsible not to check the blood samples and to have stopped the study sooner when information was available about the effectiveness of the research.
When parts of the trial had to be stopped prematurely in 2011, scientists suspected it was failing because some women were not using their gel or pills, even though they claimed they were and produced empty bottles and applicators to prove it.
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