[Letter to Donna Shalala from Neal A. Halsey and Andrea Ruff]

Oct-24-97 04:32P Please Note NEW FAX 1 410 502 6733 P02
JOHNS HOPHNS
UNIVERSITY
U V I V F. R 5 t T Y
School of Hygiene and Public Heath
Department of International Health
615 N Woite Street
Baltimore MD 21205
[phone] 1 FAX [phone]
Telex 7102340022 PUB tHYG BAL
Cable Address PUB HYG
Olviaion of Disease Control
October 24, 1997.
1.1 1111111111 Ilitt ll1l iii 11111 liii
5571095.0418.070
Donna Shalala
Secretary, Department of Health and Human Services
200 Independence Avenue, SW
Washington, D.C. 20201
Dear Secretary Shalala,
You recently received a letter from Drs. Peter Lurie and Sidney Wolfe regarding
clinical trials to evaluate zidovudine (AZT) and other antiretroviral therapy for
prevention of maternal-infant HIV transmission in developing countries. In their
letter, Drs. Wolfe and Lurie implied that we have changed our opinion regarding the
ongoing perinatal trials supported by the UNAIDS, the Centers for Disease Control
and Prevention(CDC) and the National Institutes of Health (NIH). To the contrary,
we strongly believe that these trials are ethical and essential for identifying
effective, practical regimens that could be implemented in most developing
countries.
No one study can answer all the scientific questions pertaining to the identification
of optimal regimens for use in countries with different population profiles. We and
other investigators from institutions around the world have worked together for the
past several years to design complementary studies that will provide many of the
needed answers. We had designed a placebo-controlled trial to evaluate two short
course AZT regimens that would be appropriate for Ethiopia and answer questions
about the relative impact on HIV transmission by breast feeding. Due to numerous
administrative problems the study has not yet been initiated.

Fortunately, the other trials supported by UNAIDS, CDC and NIH have been
initiated and the results of some of these studies should be available early in 1998,
well before we could complete the necessary enrollment in our planned trial, in