Cambodian HIV Clinical Trial impasse: UNAIDS mediation is essential.

Joe Thomas

International Centre for Health Equity. Inc. Melbourne.
(joe_thomas@...)

Those who are involved or interested in the outcome, methods and
ethical issues of HIV Preventive vaccine trials in developing
countries are keen to know the details of the situation in which
the Cambodian government was forced to withdraw the support for the
study " Daily Tenofovir DF to Prevent HIV Infection Among Sex
Workers In Cambodia. (1) The study was a joint project between
University of California San Francisco (UCSF; USA), the University
of New South Wales (UNSW; Australia), and the Cambodian National
Center for HIV, AIDS, Dermatology, and STDs (NCHADS) (2)

This study was expected to determine, if taking a tenofovir DF
tablet every day is safe and effective in preventing HIV infection.
Participants in the study were 960 HIV negative sex workers in
Phnom Penh, Cambodia. The clinical trial was to begin to explore
the possibility of using it as pre-exposure prophylaxis, a strategy
whereby healthy individuals at high risk of HIV take a drug prior
to exposure for the purpose of blocking infection if they are
exposed to HIV (2).

The local sex workers union "Women's Network for Unity" protested
what they perceived to be inadequate assurances for women who may
become sick during the trial. Fearing that Cambodian citizens were
being exploited for scientific research, the Prime Minister of
Cambodia halted the trial. It appears that the representatives of
the sex workers have expressed concerns about this study in early
2003 while the preparation for the study was initiated. Nevertheless
the investigators decided to go ahead with the study. (3)

While the investigators of the study were keen to highlight the
potential benefits of the study, there was no mention about the risk
and the ethical complexity of the study or plans to deal with such
dilemmas(4).

It is disturbing to see that some of agencies close to the research
investigators have began a vilification campaign against the sex
workers – blaming them for jeopardising a key AIDS Study in
Cambodia. The tenacity of the Women's Network for Unity in raising
the critical questions must be acknowledged. The fact that the
Women's Network for Unity and the other community members most
directly affected by the trial (those being recruited to participate
in it) were able to articulate their demands, protest effectively
and make their concerns heard is a testament to the power of
organizing their determination need to be applauded (5)

Some commentaors belive that cambodia has been targeted for the
clinical reserch because marginalized populations such as sex
workers are vulnerable because they lack bargaining power to
negotiate terms, and cash or insurance to obtain care if they get
sick during the trial (6)

The issues raised by this trial cancellation are of tremendous
importance to the future HIV clinical trials. It has implications
for other research collaborations, prevention trials and the
community participation in clinical trials. AIDS activist,
researchers, people infected and affected by HIV/AIDS particularly
form Asia Pacific region are closely watching the situation and want
to know what actually transpired and wish to learn from the
lessons to guide future trials.

AIDS treatment activist John S. James echoed the sentiments of many
of the AIDS activists." Hopefully these issues can be resolved
satisfactorily. Many people may live or die depending on whether the
Tenofovir HIV prevention trials are completed". (7)

It appears that the researchers have overlooked the health equity
considerations of vulnerable clinical trial participants in resource
poor setting. The current impasse is also an indication of the fact
that the UNAIDS lead series of consultation on ethical issues of HIV
prevention vaccine trial has been inadequate to reach a general
consensus on these complex issues

In this context, perhaps it may be appropriate for UNAIDS, in
collaboration with other key stake holders to conduct an impartial
assessment to inform all the concerned about the situation in which
the Cambodian government was forced to withdraw the support for the
study and to mediate for an equitable outcome.


References:
________________
( 1) Khabir Ahmad. Trial of antiretroviral for HIV prevention on
hold. The Lancet. Volume 4, Number 10 01 October 2004.
http://infection.thelancet.com/journal/journal.isa

(2) Phase 2/3 Trial of Chemophrophylaxis for HIV-1 Prevention:
Study of Daily Oral Tenofovir (Tenofovir Disoproxil Fumarate) to
Prevent HIV-1 Infection Among Sex Workers in Cambodia. Center for
AIDS Prevention Studies. Research Portfolio, Spring 2004
(3) Joan Cohen. AIDS Research: Cambodian Leader Throws Novel
Prevention Trial Into Limbo, Science 2004 305: 1092

(4) Kimberly Page Shafer. Use of ARVs in Prevention of HIV infection
in high risk populations. Women & HIV: Research Directions. XV
International AIDS Conference. Bangkok July 2003

(5) Ethical issues involved in the Cambodia Tenofovir trials
http://www.global-campaign.org/ethics_community.htm
(6) Marilyn Chase and Gautam Naik .Key AIDS Study In Cambodia Now
in Jeopardy The Wall Street Journal. August 12, 2004; Page B1
(7) John S. James. AIDS Treatment News. August 23, 2004, Issue #403