Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries.

  title={Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries.},
  author={Peter Lurie and Sidney M. Wolfe},
  journal={The New England journal of medicine},
  volume={337 12},
  • P. LurieS. Wolfe
  • Published 18 September 1997
  • Medicine, Economics
  • The New England journal of medicine
It was published almost 3 years ago that zidovudine administered orally to HIV-infected pregnant women, intravenously during labor, and later administered to newborn infants reduces the incidence of HIV infection in infants by two-thirds. This regimen, known as the ACTG 076 regimen and capable of saving the life of one of every seven infants born to HIV-infected women, subsequently became the standard of care in the US. However, the high cost of zidovudine and the ACTG 076 regimen impedes… 

Short course antiretroviral regimens to reduce maternal transmission of HIV

Placebo-controlled trials to develop simple, cheap, and effective potentially non-drug interventions against vertical HIV transmission should be encouraged in settings in which antiretroviral drugs and formula feeding cannot be safely delivered.

The prevention of perinatal HIV transmission in the less-developed world.

  • M. Susser
  • Medicine
    American journal of public health
  • 1998
This editorial refers to a set of articles that address the controversy surrounding prophylactic trials in developing countries to avert maternal-infant transmission of HIV by establishing

Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.

This letter responds to an article claiming that placebo-controlled trials of antiretroviral agents to reduce perinatal transmission of HIV in developing countries are unethical and a less traumatic observational methodology can be used to assess the efficacy of a prophylactic strategy.

Placebo controls in HIV perinatal transmission trials: a South African's viewpoint.

Any appropriate and effective intervention eventually developed for use in South Africa need not be as good as the ACTG 076 regimen of therapy but its impact upon HIV vertical transmission must be known because that information will be the basis of policy to protect hundreds of thousands of infants from becoming infected with HIV.

Preventing Mother To Child Transmission of HIV - Current strategies.

Prevention of mother-to-child HIV transmission in resource-poor countries: translating research into policy and practice.

Current knowledge of mother-to-child HIV transmission in developing countries is reviewed, key findings from the trials are summarized, future research requirements are outlined, and public health challenges of implementing perinatal HIV prevention interventions in resource-poor settings are described.

Successful prevention of hiv transmission from mother to infant in Brazil using a multidisciplinary team approach.

  • S. NogueiraT. Abreu J. Lambert
  • Medicine
    The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
  • 2001
HIV vertical transmission in Brazil was reduced to a level similar to other countries with the most effective prevention programs using a multidisciplinary team approach.

Optimal versus suboptimal treatment for HIV-infected pregnant women and HIV-exposed infants in clinical research studies.

  • A. Ammann
  • Medicine
    Journal of acquired immune deficiency syndromes
  • 2009
A randomized trial design is used to compare the emergence of viral resistance in women receiving highly active antiretroviral therapy (HAART) compared with zidovudine (ZDV) plus single-dose nevirapine (sdNVP) on the emergenceof viral resistance, and results could profoundly impact millions of lives of HIV-infected pregnant women and their noninfected infants.



Reduction of maternal-infant transmission of human immunodeficiency virus 1 with zidovudine treatment

It was shown that AZT decreased the maternal-infant transmission of HIV and helped decrease infant mortality due to the viral infection.

Perinatal HIV infection and the effect of zidovudine therapy on transmission in rural and urban counties.

Health care providers in North Carolina are identifying most of the state's HIV-seropositive pregnant women, treating them with zidovudine, and testing their infants soon after birth for HIV infection, which has reduced perinatal HIV transmission in the state.

Timing of mother‐to‐child HIV‐1 transmission depends on maternal status

The greater the degree of maternal immunodeficiency at delivery the higher the risk of in utero transmission, showing that vertical transmission is dependent on the mother's immunological status.

Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries.

Nine investigators from Africa, Asia, North America, and South America reviewed previous experience with HIV trials in developing countries and explored potential solutions to these issues.

Paediatric HIV infection

Effect of vitamin-enriched bread on the vitamin status of an isolated rural community--a controlled clinical trial.

Fortification of food staples has been successfully implemented in a number of countries to increase the dietary intake of micronutrients.

Equipoise and the ethics of clinical research.

  • B. Freedman
  • Medicine, Psychology
    The New England journal of medicine
  • 1987
An alternative concept of equipoise is suggested, which would be based on present or imminent controversy in the clinical community over the preferred treatment, which is satisfied if there is genuine uncertainty within the expert medical community--not necessarily on the part of the individual investigator--about the preferredreatment.

Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths

  • B. FreedmanC. WeijerK. Glass
  • Medicine
    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
  • 1996
The case against placebos is presented in a compendious form that takes account of scientific and statistical as well as normative issues.

International ethical guidelines for biomedical research involving human subjects

This is a very seriously written book which is, incidentally, beautifully edited and well produced and it is essentially for educationists and community physicians who will follow the discussions with interest and benefit.