Thursday, February 05, 2015

Blog #1: A Failed Trial in Africa Raises Questions About How to Test H.I.V. Drugs

A Failed Trial in Africa Raises Questions About How to Test H.I.V. Drugs
In Africa, there are 1.6 million new infections of the human immunodeficiency virus each year. Women are at a greater risk of being infected with the disease, and teenage girls are more likely to be infected versus teenage boys.

Vaginal and Oral Interventions to Control the Epidemic, better known as Voice, was a trial conducted in Africa but was abruptly stopped. This study was supposed to definitively establish whether pre-exposure use of small amounts of anti-AIDS drugs to prevent infection would work for African women. Independent safety monitors halted this experiment because women who were given the pills or vaginal gels containing anti-H.I.V. drugs were becoming infected at the same rate as the women who were given placebos. This study enrolled 5,029 women at fifteen clinics located in South Africa, Zimbabwe, and Uganda.

When parts of the Voice trial was ceased in 2011, scientists assumed it failed because some women were not using their gel or pills, even though they claimed to be. Luckily, all of the blood samples were stored for later testing. The New England Journal of Medicine said that about seventy percent of the women actually had no tenofovir, the main study drug, in their blood.

Because the participants were paid for participating in this trial, scientists are now passionately arguing about the extent to which it is ethical to pay participants for their time, and whether or not results of trials that do so can be reliable and valid.

Honestly, I believe that it is imperative to be cognitive of the demographics of the participants. By this, I mean that understanding the location of where the trial will be taking place is important. In this case, the study was conducted in Africa, a poor country. Paying African women to participate in this study was a good idea because it offers incentives for the women: a possible prevention for a high-risk infection and source of revenue. However, as a researcher, you should consider if all of the women are sincerely willing to participate for the prevention analysis, or are solely participating for the money and not caring about the end result.

Shane’ Lennon
3:10 pm

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