Conference Summary [Conference on Global Strategies for the Prevention of HIV Transmission from Mothers to Infants (1997)]

The Question of Placebo-Controlled Trials
As with nearly every aspect of HIV, the effort to prevent mother-to-infant
transmission is not without controversy. The CDC and NIH recently have come
under some criticism for sponsoring international clinical trials that use placebocontrolled methods to study perinatal transmission in developing countries.
In a placebo-controlled study, half the participants receive the medication
being studied and the other half receive a placebo, or sugar pill. But placebos, in
most cases, are not used once a medication has been proven effective. For
example, when researchers saw clear evidence that the ACTG 076 regimen
could prevent perinatal transmission, they stopped the study early, so the women
who had been receiving placebos could begin the proven regimen. It would have
been considered unethical to proceed with the placebo arm of the trial once the
researchers knew the ACTG 076 regimen worked.
Critics of the CDC and NIH have argued it's therefore unethical for
researchers from industrialized countries to do placebo-controlled studies on
women in developing countries when they know the ACTG 076 regimen is
effective. Instead, critics argue, scientists should compare the long course of
AZT used in the ACTG 076 regimen with other antiretroviral regimens, such as a
shorter course of AZT.
But conference participants from both industrialized and developing
nations argue that testing the ACTG 076 regimen on women in developing
nations would do no good because there is no way those countries could ever
administer such an expensive, prolonged method of treatment.
"The difficulty we have here is not that we in developing countries do not
want to use 076," said Edward Katongole-Mbidde, MBChB, Mmed., director of
the Uganda Cancer Institute in Kampala, Uganda.
"The problem is we cannot afford 076 because of the cost of the drug and
because of the logistics that are necessary to make it work," said Dr. Mbidde.
"The whole idea now is to say what would be the best regimen for our people?
What would be practical and applicable in our countries?"
Other conference participants echoed Dr. Mbidde's comments.
"We need to study in developing countries regimens that we can, in the
end, leave the country with, something they can potentially use," said Lynne
Mofenson MD, Associate Branch Chief for Clinical Research at the National
Institute of Child Health and Human Development.
"If one does a trial where one compares 076 to something else and 076
turns out to be the most effective therapy, what have you left that country with to
use, if they can't possibly use the 076 regimen?" Dr. Mofenson said.
"The fact is that treatment is not the same in one country as it is in every
other, due to the grim realities of economic inequities," said Dr. Gayle of the
CDC.
She urged conference participants to use this fact as motivation and not
as a reason to give up hope.
"Acceptance of this tragedy as a reality that cannot be changed is not
acceptable morally, not realistic practically and not defensible intellectually," said
Dr. Gayle.

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