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The Debate Over Clinical Trials of AZT
to Prevent Mother-to-Infant Transmission of HIV
in Developing Nations
In 1994, researchers in the US and
France announced stunning news of a rare victory in the battle against the AIDS
pandemic. Studies conducted in both countries had shown conclusively that a
regimen of the drug AZT, administered prenatally to HIV-positive pregnant women
and then to their babies after birth, reduced the rate of mother-to-infant transmission
of HIV by fully two-thirds. The results of the clinical trials constituted "one
of the most dramatic discoveries of the AIDS epidemic," the New York Times
declared,
and one of the most heartening as well.
The new regimen--known by its study
name, AIDS Clinical Trials Group (ACTG) 076 or, often, simply "076"--offered
the epidemic's most vulnerable targets, newborns, their best hope thus far of
a healthy childhood and a normal life span. The number of infants who might
benefit from this research was significant: according to World Health Organization
(WHO) figures, as many as five to ten million children born between 1990-2000
would be infected with HIV. In the mid-1990s, it was estimated that HIV-infected
infants were being born at the rate of 1,000 a day worldwide.
So impressive were the findings
of ACTG 076--and so substantial the difference in the transmission rate between
subjects given AZT and those given a placebo (eight percent versus 25 percent)--that
the clinical trials, which were still ongoing, were stopped early, and all participants
in the studies were treated with AZT. In June 1994, after reviewing the study
results, the US Public Health Service recommended that the 076 regimen be administered
to HIV-infected pregnant women in the US as standard treatment to prevent transmission
of the virus.
But while 076 was hailed as a major
breakthrough, the celebration was somewhat muted. For a variety of reasons, the
new treatment regimen would not likely reach those who most desperately needed
it: pregnant women in the developing nations of the world and, most particularly,
sub-Saharan Africa, where AIDS was wreaking devastation on a scale unimagined
in the West. 
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