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Tenofovir is an HIV drug that works by
inhibiting an important enzyme in the HIV
life cycle prevented from invading cell that have not yet been infected with the virus.
Ordinarily, when taken as a pill, Tenofovir is said to be long lasting, with relatively few side effects, and HIV is slow to develop resistance to it. Studies in monkey also show that it can prevent transmission of a virus that is similar to HIV, but it is not yet known if it has the same effect on humans. The intended trial is to determine the safety and effectiveness of daily oral Tenofovir to prevent HIV infection among heterosexual human at high risk.
A total risk of 1,200 female volunteers from Ghana, Cameroon, and Nigeria will be recruited over a period of 6 months, and each individual will be enrolled for 12 months in the study being co-sponsored by the Gates Foundation and the Family Health International. To be eligible, volunteers must be sexually active HIV- uninfected women between ages 18 and 35 years.
Dust-raising issues
So the question/controversy being raised by Nigerian advocates, led by the Nigeria HIV vaccine and Microbicide Advocacy Group (NHVMAG) is the extent of adherence to international trial standards and informed consent ethics in Nigeria? What amount of post-trial care would be given to participants in the event of HIV during the trial? Nigerians demand to be assured that the research study offers a rigorous ethical process and the best benefits to trial participant and the Nigerian public.
Reassurances or dismissals?
According to Elizabeth Robinson Director Information Programmes, Institute for Family Health. Family Health International, “A detailed informed consent process is also be used to ensure that volunteers understand all risks and benefits of trial participation and know that they are not obligated to participate and can stop participating at any time. Throughout the trial, the investigators will also adhere to strict national and international procedures for monitoring any serious adverse experiences to the appropriate regulating agencies.” Speaking about the overall safety of Nigeria’s trial participants on the NHVMAG website, she stated, “In addition to counselling to HIV transmission and prevention, provision of condoms, and careful monitoring of any side effects, multiple safeguards are in place to protect the physical and psychological well-being of participants.”
Professor Isaac Adewole, Provost, College of Medicine University of Ibadan, Nigeria, in a posting on NHVMAG website said “The International Review Committee (IRC) of the COM/UCH is the foremost in this country and has a sound culture of good conduct.
Responding, Omololu Falobi of Journalists Against AIDS, Nigeria said, issues of scientific processes with impact on public health should be subjected to rigorous debate by interested public-minded stake-holders. The perception of science as a sacred masquerade that only a restricted circle of anointed acolytes can view, is no longer acceptable.
Unanswered issues
Though the people involved in the trial haves consistently reiterated their commitment to utmost adherence of international trial standards, the issue of post-trial care – providing life long treatment for participants who get infected during the trial duration- is not being answered forthrightly.
From information gathered by NewAge, the Tenofofvir trial is meant to see if the drug can prevent HIV infection. That implies that the participants do not have HIV but are at high risk of being infected.
Without transparency, the trial runs the risk of a lack of trust, besides heightening the suspicion that some of the world’s most vulnerable people are viewed as not any more valuable than guinea pigs.
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