Final Program [International AIDS Society (11th: 1996: Vancouver, Canada)]

VENUE ROOM TRACK SESSION NO. TIME/SESSION PATHWAYS
1..

D2
Ballroom C

155 Track D: Social Science: Research, Policy & Action
Roundtable:
Clinical Trials In Developing Countries - Ethical Dilemmas
Chair:
Fernando Zacarias, USA

A multi-disciplinary panel will explore the ethical dilemmas raised by clinical trials in developing countries.
Case Study
ABEC Company, a major multinational pharmaceutical company based in a developed country, is in the process of developing an antiretroviral drug, Innovudine. Pre-clinical and phase 1/11I studies indicate that the drug has antiretroviral effects, as evidenced by increased
CD4 counts and a reduction of RNA viral load of almost two logs in asymptomatic HIV seropositive subjects, sustained for at least 12
weeks after start of the drug when administered at 300 mg twice a day. A high or more frequent dosing had similar antiviral effects,
but was associated with a high incidence of nausea and skin reactions.These studies were conducted in ABEC's home country where
optimal access to excellent health care and support was available and assured.The cost of the drug is anticipated to be in the range
of currently available antiretrovirals, that is, around $US 10 a day.
ABEC now wishes to proceed with a phase II/111I trial in PARAZIA, a developing country with a high prevalence of HIV ABEC believes
that it is necessary to conduct the phase II/111I trial in a country such as PARAZIA, because it cannot find a sufficiently large cohort of
antiretroviral-naive HIV positive people in an industrialised country to conduct the trial successfully Conducting the trial in PARAZIA
would lead to much earlier marketing of the product. In PARAZIA, the annual per capita income is US $250.The annual amount spent
per capita on health is $US8.
The protocol is a double-blind, placebo-controlled trial calling for enrollment of 500 persons with advanced HIV infection (ARC
and < 200 CD4 cells/mm3 or AIDS). During their participation in the trial, the participants would receive free access to medical
follow-up, to drugs to treat inter-current illness according to clinical practice guidelines in PARAZIA, and to counselling concerning
HIV infection. Study visits will be monthly, involve a physical examination, and blood tests to monitor drug toxicity and immunological
and virological markers. Interim analysis is foreseen each time 100 participants have completed 24 weeks of follow-up, and the trial
will be stopped after a significant difference in progression to the next AIDS-defining event or death is evident at a significance level
of p<0.00I, or after the last subject has completed 24 weeks of follow-up, whichever comes first. After conclusion of the trial, and
S in the event Innovudine proved superior to the placebo, participants would also be offered free treatment with Innovudine for the
remainder of their lives.
S ABEC will also significantly strengthen the research capabilities of the Medical School of the University of PARAZIA by improving its
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S laboratory and Department of Epidemiology, and will renovate its outpatient clinic. It is clear that those participating in the trial and
> average citizens of PARAZIA would not be able to afford Innovudine without significant financial and health care support. Nor does
LI ABEC intend to market Innovudine in PARAZIA or other developing countries at a preferential price. Nevertheless, it is felt that the
benefits gained by the participants in the study and by PARAZIA by letting its university conduct the trial are sufficient to claim benefic cence of the trial to the country. Ethical clearance for the study is requested.
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a)
U Ethical Issues
a)
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a Should the trial be allowed to go ahead? Should it be modified?
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~ What ethical concerns are raised, e.g. voluntary participation, subject selection and support, confidentiality, distributive justice, access
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o to results and products, implementation of service component?
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(* How should these ethical considerations be assessed and by whom?
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