doi: 10.1056/NEJM199709183371212.
Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries
Affiliations
- PMID: 9295246
- DOI: 10.1056/NEJM199709183371212
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Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries
N Engl J Med.
.
Abstract
PIP: 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 their use in developing countries. A regimen as effective but less expensive than ACTG 076 is therefore highly desirable in countries worldwide, but especially in developing countries. The authors oppose the use of placebo-controlled trials as unethical in the search for alternative antiretroviral drug regimens to prevent the perinatal transmission of HIV. 15 trials in developing countries are identified in which some or all of the participants are not being provided with antiretroviral drugs. Those studies violate recent guidelines designed specifically to address ethical issues regarding studies in developing countries. An urgent need exists to develop and adhere to a universally recognized code of ethics for medical research upon human subjects.
Comment in
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The ethics of clinical research in the Third World.N Engl J Med. 1997 Sep 18;337(12):847-9. doi: 10.1056/NEJM199709183371209. N Engl J Med. 1997. PMID: 9295243 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):836; author reply 840-1. doi: 10.1056/NEJM199803193381213. N Engl J Med. 1998. PMID: 9508627 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):836-7; author reply 840-1. N Engl J Med. 1998. PMID: 9508628 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):837; author reply 840-1. N Engl J Med. 1998. PMID: 9508629 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):837; author reply 840-1. N Engl J Med. 1998. PMID: 9508630 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):837-8; author reply 840-1. N Engl J Med. 1998. PMID: 9508631 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):838; author reply 840-1. N Engl J Med. 1998. PMID: 9508632 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):838; author reply 840-1. N Engl J Med. 1998. PMID: 9508633 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):838; author reply 840-1. N Engl J Med. 1998. PMID: 9508634 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):838-9; author reply 840-1. N Engl J Med. 1998. PMID: 9508635 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):839; author reply 840-1. N Engl J Med. 1998. PMID: 9508636 No abstract available.
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Ethics of placebo-controlled trials of zidovudine to prevent the perinatal transmission of HIV in the Third World.N Engl J Med. 1998 Mar 19;338(12):839; author reply 840-1. N Engl J Med. 1998. PMID: 9508637 No abstract available.
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Informed consent for a clinical trial in Thailand.N Engl J Med. 1998 Oct 29;339(18):1331-2. doi: 10.1056/NEJM199810293391815. N Engl J Med. 1998. PMID: 9841301 No abstract available.
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