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PROCAARE: Trials of AZT in African countries (06)
[See also 970520100046
970513191334
970513192645
970515090445 - Mod.]
This is a response from the Division of AIDS, NIAID Medical Officer
for Perinatal Studies regarding the note from Ann Smith on perinatal
HIV trials in developing countries.
In her email Ms Smith echoes concerns raised by the Public Citizen
Health Research Group about short course antiretroviral trials in
developing countries which involve placebo drugs. This is clearly a
complicated issue which has been widely debated and discussed in
international forums since the results of the US ACTG 076 clinical
trial became available in 1994.
It is important to understand that only this very intensive regimen of
AZT has been proven to work. It includes AZT given to the mother
beginning in the second trimester, administered intravenously during
labor, and given to the baby 6 weeks of AZT postnatally.
Tragically, this regimen is simply not deliverable in most of the
developing world and therefore 1000 babies per day continue to be born
HIV infected. There are a number of reasons that the 076 regimen is
not a viable option in many international settings: most pregnant
women show up in health care systems only around the timing of
delivery; the impossibility of widespread intravenous drug
administration; and the prohibitive cost of the 076 AZT regimen which
is several hundred times the per capita health care expenditure costs
of developing countries.
Thus, there is a critical need and demand for alternative therapies
to reduce perinatal transmission in the developing world. Hence the
need to test the trials, and to compare them to the standard of no
treatment to make sure that 1) they are not associated with increased
risk 2) to determine definiteively if the short course strategies add any
benefit over the current standard of no treatment given that the
intensive 076 regimen is not feasible to deliver.
Ms Smith suggests that historical controls be used instead of a
randomized placebo controlled trial. Use of historical controls is
fraught with problems in this setting where there is in fact a wide
confidance interval around the historical baseline. For example, what
if a short course AZT yielded a one third reduction in transmission at
the end of a 3 year study? Without a concurrent control group treated
according to the current standard of care, one wouldn't know if
temporal changes or the new regimen were responsible. It would be a
disservice to the countries and women in the trials to take part in a
study likely to yield uninterpretable information.
Ms Smith raises an important question regarding the long term
implications of the trials. These trials have been developed as
collaborations involving investigators from developing countries, the
U.S., Europe and UNAIDS. The goals of these studies are to find
strategies that are feasible, effective and which can be delivered in
these settings. They have all undergone extensive in-country and U.S.
ethical review. Plans are underway to enable developing countries to
access these drugs long term once a successful and deliverable
intervention is found.
To summarize, approximately 1000 HIV-infected babies are being born
each day despite a proven effective intervention. These trials have
been designed to identify as quickly and as accurately as possible,
regimens which might actually be implemented in those settings where
the U.S. intensive AZT regimen cannot be delivered. They are
addressing a critical global public health need. They have been
developed by the investigators from the developing countries with the
support of and in collaboration with investigators from US and Europe.
They have undergone extensive in-country and U.S. ethical review.
MaryGlenn Fowler <[email protected]>
KEYWORDS: CLINICAL SCIENCES--VERTICAL TRANSMISSION--AZT--ETHICS
............................................................gjn
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