6 Years and Counting: Can a Shifting Landscape Accelerate an AIDS Vaccine?

may have an impact later, in the course of the disease,
even if it doesn't stop the initial HIV infection itself.
Unfortunately, there is a possibility that more pressure
to provide the "best current treatment" might not
result in more ethical trials, but in a delay in the
start of new preventive HIV vaccine trials. This
potential risk is particularly true for trials in the least
developed nations. Providing this level of treatment,
even for the few hundred participants who potentially
would get infected in studies that can include thousands, will be difficult to achieve.
FINDING A WORKABLE PATH
Perhaps the strongest argument against providing
anti-retroviral therapy in a country where it is otherwise practically unavailable has been that it would
provide an undue inducement to join a vaccine
study. Some believe that this argument is seriously
flawed since trials, as currently designed, already
include "inducements," such as routine health checkups and other benefits that are not currently available
to the general population. More troubling is the fact
that trials with subsequent treatment may not be as
relevant where subsequent treatment will not be
available outside the trial, since trial conditions no
longer match those of the general population.
In recent years, access to anti-retroviral treatment
has been expanding in many developing countries,
especially in Latin America and Asia. Effective,
although perhaps not optimal, therapies are being
achieved with fewer drugs and without some of the
very expensive protease inhibitors. Companies in
Brazil, India and Thailand are making generic
versions of these drugs, and these are available at
substantially lower prices. While Brazil and Thailand
make enough product to satisfy their local demand,
Indian companies such as Cipla and Ranbaxy
Laboratories intend to make enough product to
export to Africa and other less developed nations.

Recognizing the changing situation, the major pharmaceutical companies have begun lowering the prices to
developing countries and participated in private meetings
with the World Trade Organization and World Health
Organization in April 2001 to begin discussion of drug
access issues.
It is true that questions remain about the sustainability
of and access to the drug programs, but anti-retroviral
drugs have become, in some developing nations, part
of their highest attainable standard of care. While
this is far less true in the poorest countries, particularly in hardest hit Africa, it is increasingly difficult
to justify no provision of at least a minimum of
anti-HIV medications to the infected population.
As community vaccine advocates in a country that
generally provides Highly Active Anti-Retroviral
Therapy (HAART), considered the "best current
treatment," for HIV disease and AIDS, AVAC
supports all efforts to expand access to HAART in
developing countries. Of equal importance, AVAC
supports HIV vaccine clinical trials with sound ethical
standards starting as soon as possible. How can we
reconcile these two issues, which are seemingly at odds?
It is clear that in developing countries where either
HAART, or (at a minimum) proven effective antiretroviral treatment therapies are available, the same
treatments should be available for vaccine trial participants who become infected during the trial. But
what about the poorest countries that currently lack
any significant provision of treatment for the infected
and, in general, are the ones most desperate for an
HIV vaccine?
First, we think the urgency of the epidemic demands
that we initiate HIV vaccine trials as soon as possible,
without throwing more roadblocks in the already
difficult path these trials face. This may mean that, in
some instances, HIV vaccine trials begin without the
issue of therapy for trial participants completely resolved.

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