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Volume 337:853-856 September 18, 1997 Number 12
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Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries

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It has been almost three years since the Journal1 published the results of AIDS Clinical Trials Group (ACTG) Study 076, the first randomized, controlled trial in which an intervention was proved to reduce the incidence of human immunodeficiency virus (HIV) infection. The antiretroviral drug zidovudine, administered orally to HIV-positive pregnant women in the United States and France, administered intravenously during labor, and subsequently administered to the newborn infants, reduced the incidence of HIV infection by two thirds.2 The regimen can save the life of one of every seven infants born to HIV-infected women.

Because of these findings, the study was . . . [Full Text of this Article]

Asking the Wrong Research Question

Inadequate Analysis of Data from ACTG 076 and Other Sources

Defining Placebo as the Standard of Care in Developing Countries

Justifying Placebo-Controlled Trials by Claiming They Are More Rapid

Toward a Single International Standard of Ethical Research

References


Related Letters:

Ethics of Placebo-Controlled Trials of Zidovudine to Prevent the Perinatal Transmission of HIV in the Third World
Merson M. H., Simonds R.J., Rogers M. F., Dondero T. J., Francis D. P., Mbidde E. K., Blanche S., Kim R. J., Sharif S. K., Tafesse E., Murphy T. F., IJsselmuiden C. B., Herrington D., Piot P., Glantz L. H., Grodin M. A., Lallemant M., McIntosh K., Jourdain G., Le Coeur S., Vithayasai V., Lee T.-H., Hammer S., Prescott N., Essex M., Lurie P., Wolfe S. M.
Extract | Full Text  
N Engl J Med 1998; 338:836-841, Mar 19, 1998. Correspondence

Informed Consent for a Clinical Trial in Thailand
Achrekar A., Gupta R., Pichayangkura C., Chokewiwat V., Limpakarnjanarat K., Chuachoowong R., Bhadrakom C., Siriwasin W., Chearskul S., Chotpitayasunondh T., Shaffer N.
Extract | Full Text  
N Engl J Med 1998; 339:1331-1332, Oct 29, 1998. Correspondence

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