[afro-nets] Nigeria: Controversy over trial of HIV/AIDS drug (2)

[David Hock <DHock@fhi.org>]

Nigeria: Controversy over trial of HIV/AIDS drug (2)
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We have read the Sept. 26 postings on AFRO-NETS, and are happy
to provide information on the oral tenofovir study. Family
Health International (FHI) believes that to defeat the HIV/AIDS
epidemic, it is essential to develop new tools and technologies
to stop HIV transmission. Ethical, scientifically sound clinical
trials are the only way to make these kinds of research ad-
vances, and we are proud of our partnership with researchers in
Africa to identify effective approaches for prevention. Family
Health International is committed to continuing discussions with
the community and to providing up-to-date information on the
trial as it progresses.

Seven countries, including the United States, are now testing or
will soon test the oral form of tenofovir as an HIV prevention
approach. Family Health International is involved in a clinical
trial in three African countries to determine the safety and ef-
fectiveness of daily oral tenofovir to prevent HIV among hetero-
sexual women at high risk of infection. The study is also being
planned in a fourth African country to determine whether teno-
fovir can safely and effectively prevent HIV among high-risk
heterosexual men. Local African researchers are conducting the
trial. Ibadan, Nigeria, is one of the three study sites recruit-
ing women.

This study was designed according to the most rigorous interna-
tional ethical standards. It has been reviewed by a special eth-
ics committee devoted to protecting participants in human re-
search, convened by Family Health International. The study has
also been approved by Family Health International's institu-
tional review board and by numerous ethics groups in Africa.
Members of these committees include ethicists, researchers, law-
yers, and community representatives, among others. In Nigeria,
for example, the trial was approved by the Institutional Review
Committee (IRC) of the College of Medicine, UCH, which reviewed
both the science and ethics of the trial. Professor Isaac F.
Adewole, Provost, College of Medicine, University of Ibadan, has
invited interested parties to contact either him or Professor
Gladys Adeyinka Falusi, Chair, COM/UCH IRC, Protem Chair, Nige-
rian Bioethics Initiative (NIBIN), at the Institute for Advanced
Medical Reseach and Training at the College of Medicine with any
questions on the IRC review process. In addition, the tenofovir
trial is supported by nongovernmental organizations, community
groups, and governments in Nigeria and the other study coun-
tries.

Tenofovir is not a new drug. It has been proven to be safe as a
treatment for HIV and is one of 20 antiretroviral drugs already
approved by regulatory agencies and used by thousands of indi-
viduals throughout the world to treat HIV infection. Tenofovir
works by inhibiting an important enzyme in the HIV life cycle,
called nucleotide reverse transcriptase. By doing so, tenofovir
stops HIV from invading cells that have not yet been infected
with the virus. It is taken in the form of a pill, it is long
lasting, it has relatively few side effects, and HIV is slow to
develop resistance to it. Tenofovir is manufactured and being
provided free of charge for the study by Gilead Sciences, lo-
cated in Foster City, California.

Multiple safeguards are in place to protect the physical and
psychological well-being of participants in the tenofovir study,
in addition to counseling on HIV transmission and prevention,
provision of condoms, and careful monitoring of any side ef-
fects. A detailed informed consent process is being used to en-
sure that volunteers understand all risks and benefits of trial
participation and know that they are not obligated to partici-
pate and can stop participating at any time. Throughout the
trial, the investigators will also adhere to strict national and
international procedures for monitoring and reporting any seri-
ous adverse experiences to the appropriate regulating agencies.

Those who do become infected will have enhanced referral to HIV
care and support services, including antiretroviral drugs when
necessary. Local investigators have identified facilities within
the study countries that offer HIV-related psychological, so-
cial, and medical services, and participants who become infected
will be counseled and referred to those sites. In Ibadan, Nige-
ria, for example, FHI is working with our partner organization,
Harvard University, co-funded under PEPFAR to serve the Ibadan
area, to provide the priority HIV care and services needed for
the participants. Those who experience medical problems that are
directly related to their participation in the trial will re-
ceive medical services for those problems free of charge.

Local communities have been instrumental in preparing for the
trial. Through state-of-the-art social and behavioral research
conducted by Family Health International, community members, in-
cluding potential study participants, have provided information
that helped identify areas where potential participants may be
found. They have also been pivotal in identifying available lo-
cal services offering HIV care and support, which will enhance
referral of participants who become infected with HIV and those
who test positive for HIV during screening. Mechanisms have also
been created so that a variety of stakeholders can provide feed-
back on the trial and advise on how to effectively implement re-
search results to support HIV prevention and treatment in the
local community.

The well-being of study participants is FHI's highest priority,
and we are pleased to be part of the international network of
organizations working to improve public health, including the
many excellent groups in Nigeria devoted to preventing HIV/AIDS.

Sincerely,

Elizabeth Robinson
Director, Information Programs
Institute for Family Health
Family Health International
PO Box 13950
Research Triangle Park, NC 27709 USA
mailto:media@fhi.org