1000 Foreign Infants to Die Unnecessarily in US-Funded HIV Studies: Human Experiments are Tuskegee Part Two, Says Health Groups

approximately January 1997 by Dr. Joseph Saba of the United Nations AIDS program
that summarizes studies of mother-to-infant transmission which have either begun
since the completion of the historic Protocol 076 trial or are about to begin (see
attached). Other information about these studies was obtained from the Pediatric and
Family Studies Section, Epidemiology Branch, Division of HIV/AIDS Prevention, CDC.
The studies evaluate a variety of potential interventions: AZT (or other similar anti-HIV
drugs), usually in regimens less expensive or complex than in Protocol 076;
nevirapine, another anti-HIV drug; Vitamin A; vaginal washes; and HIV immune
globulin (a form of immune therapy). The studies involving AZT generally explore the
optimal dose and timing of AZT administration. A total of 17 studies appear in the
table, two of which are in the U.S. The remainder are in developing countries, primarily
in Africa: three studies each in Cote d'lvoire and Uganda, two studies each in
Thailand, Tanzania and South Africa, and one study each in Ethiopia, Burkina Faso,
Malawi, Zimbabwe, Kenya, and the Dominican Republic. Two studies are occurring at
more than one site. VWe are also aware of an additional study in Malawi that has been
completed but is not in the table. This study enrolled 2,094 women in an NIH-funded
study of vaginal washing."7 Of the studies in the table, two have been completed: the
NIH-funded study by Johns Hopkins University in Malawi, the data from which are now
being analyzed, and the NIH-funded ACTG 185 in the U.S., which was terminated
early when the transmission rate from the women, all of whom received AZT, to their
infants was about 4.8%, even lower than in the treatment group in Protocol 076.18
The two studies in the U.S. both provide anti-HIV drugs to all study subjects,19
as does one of the studies in the developing countries, that conducted by Harvard
University in Thailand using NIH funds. This leaves 15 randomized, controlled trials
(including the one study not in the table), all in developing countries in which some or
all HIV-infected pregnant women are denied effective prophylaxis. Seven of the 15
studies are funded by the NIH and two are funded by the CDC. A total of 9,055
women are enrolled in the nine U.S.-funded studies, 2,903 of whom will receive
placebos and 3,780 of whom will receive regimens not proved effective in randomized,
controlled trials. The remaining six studies are funded by the ANRS (the French
equivalent of the NIH; two studies), the United Nations AIDS program, the University
17 Biggar RJ, Miotti PG, Taha TE, et al. Perinatal intervention trial in Africa: effect of a
birth canal cleansing intervention to prevent HIV transmission. Lancet 1996:347:1647-1650.
18 Brown D. AZT effective in pregnancy with advanced AIDS. Washington Post, March 27,
1997, p. A6.
19 Even though this is listed as a placebo-controlled study, subjects in ACTG 316 receive
AZT in a regimen similar to that studied in Protocol 076 or another anti-HIV drug, unless their
physician decides it is not indicated. The study examines whether the addition of intrapartum
and postpartum nevirapine confers added protection from infection.