The ethics of placebo-controlled trials for perinatal transmission of HIV in developing countries

Journal of Clinical Ethics

Volumn 9, Issue 2, 1998, Pages 156-166

  Clark, Peter A ^a  

^a SAINT JOSEPH S UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ZIDOVUDINE;

ANALYTICAL APPROACH; ARTICLE; BENEFICENCE; BIOMEDICAL AND BEHAVIORAL RESEARCH; COMPREHENSION; CONTROL GROUP; DEVELOPING COUNTRY; DISEASE TRANSMISSION; DOSE RESPONSE; ETHICS; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTERNATIONAL COOPERATION; LEGAL ASPECT; MEDICAL ETHICS; MISCELLANEOUS NAMED GROUPS; NEWBORN; PERSONAL AUTONOMY; PREGNANCY; PREGNANCY COMPLICATION; PREGNANT WOMAN; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUBJECT; RISK ASSESSMENT; SOCIAL JUSTICE; TREATMENT OUTCOME; VULNERABLE POPULATION;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH;

ANTI-HIV AGENTS; BENEFICENCE; COMPREHENSION; CONTROL GROUPS; DEVELOPING COUNTRIES; DISEASE TRANSMISSION, VERTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; ETHICAL ANALYSIS; ETHICAL RELATIVISM; ETHICS, MEDICAL; FEMALE; HIV INFECTIONS; HUMANS; INFANT, NEWBORN; INTERNATIONALITY; PERSONAL AUTONOMY; PERSONS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANT WOMEN; RANDOMIZED CONTROLLED TRIALS; RESEARCH SUBJECTS; RISK ASSESSMENT; SOCIAL JUSTICE; TREATMENT OUTCOME; VULNERABLE POPULATIONS; ZIDOVUDINE;

EID: 0032086621     PISSN: 10467890     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. The Tuskegee Syphilis Study was initiated by the United States Public Health Service in 1932 to study poor African American men with syphilis in Macon County, Alabama, to determine the natural course of untreated syphilis in Black males. For a more detailed analysis of this study, see J.H. Jones, Bad Blood: The Tuskegee Syphilis Experiment - A Tragedy of Race And Medicine (New York: Free Press, 1981).
2. M. Angell, "The Ethics of Clinical Research in the Third World," New England Journal of Medicine 337 (18 September 1997): 847.
3. Centers for Disease Control and Prevention (CDC), HIV/AIDS Surveillance Report? (June 1997): 3.
4. It should be noted that of the five currently approved nucleoside analogue antiretrovirals, only AZT and lamivudine (3TC) pharmacokinetics have been evaluated in clinical trials in human pregnancy to date. For more detailed information, see Depart ment of Health and Human Services, U.S. Public Health Service Recommendations for Use of Antiretroviral Drug During Pregnancy for Maternal Health and Reduction of Perinatal Transmission of Human Immunodeficiency Virus Type 1 in the United States, draft copy (Washington, D.C.: Office of Public Health and Science, 6 August 1997), 5.
5. A Phase I study in the U.S. evaluated the safety and pharmacokinetics of nevirapine in seven HIV-1-infected pregnant women and their infants. Nevirapine was administered as a single 200 mg oral dose at the onset of labor, and a single dose of 2 mg per kg body weight at two to three days of age to their neonates. The drug was well-tolerated by the women and no short-term adverse effects were observed in mothers or neonates. U.S. Public Health Service Recommendations for Use of Antiretroviral Drug during Pregnancy for Maternal Health and Reduction of Perinatal Transmission of Human Immunodeficiency Virus Type 1 in the United States., p. 7.
6. For a more detailed analysis, see M. Mirochnick et al., "Safety and Pharmacokinetics of Nevirapine in Neonates Born to HIV-1 Infected Women," (paper presented at the Fourth Conference on Retroviruses and Opportunistic Infections, Washington, D.C. 22-26 January 1997), abstract #723. Delavirdine has not been studied in pregnant women. Efavirer will become available in the fall of 1998.