International Journal of Clinical Pharmacy

, Volume 35, Issue 6, pp 1203–1207 | Cite as

Geographic location of antiretroviral clinical trials in HIV infected pediatric patients

  • Katie J. SudaEmail author
  • Jodie Greene
  • Chasity M. Shelton
Research Article


Background Some medicines regulatory authorities are encouraging research in pediatrics. However, children are a vulnerable population, and previous studies have suggested that research is increasingly being conducted outside of developed countries. Objective The purpose of this study is to determine the location of trials in the pediatric population with human immunodeficiency virus (HIV). Setting Not applicable. Methods Clinical trials registered in the largest international clinical trials registry ( evaluating antiretrovirals in pediatric HIV infected patients were included. Data were collected on the location, funding, study purpose, design, initiation date, age of subjects, and medication classes tested. Main outcome measures We assessed frequencies of characteristics of pediatric HIV trials registered in the database. Results Overall, 288 studies were included in the analysis. Most trials were conducted in ages 12–17 years (83 %), followed by studies in those <6 years (25 %) and 6–11 years (21 %). The location of most trials included at least one site in developed countries (83 %). The number of trials completed exclusively in developing countries increased from 1989 to 2011. Conclusions The majority of pediatric antiretroviral trials registered in were conducted in adolescent subjects in developed countries. The number of pediatric HIV studies in developing countries increased while studies conducted in developed countries decreased similar to trends of HIV.


Clinical trial Ethics Geographic location HIV infection Pediatrics 




Conflicts of interest



  1. 1.
    Christensen ML, Helms RA, Chesney RW. Is pediatric labeling really necessary? Pediatrics. 1999;104(3 Pt 2):593–7.PubMedGoogle Scholar
  2. 2.
    Blumer JL. Off-label uses of drugs in children. Pediatrics. 1999;104(3 Pt 2):598–602.PubMedGoogle Scholar
  3. 3.
    Tabor E. FDA requirements for clinical studies in pediatric patients. Regul Focus. 2009;14:16–21.Google Scholar
  4. 4.
    European Medicines Agency [Internet]. London: EMA; 2007 [date unknown] [cited 2013 July 24]. Available from:
  5. 5.
    Glickman SW, McHutchinson JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816–23.PubMedCrossRefGoogle Scholar
  6. 6.
    US National Institute of Health [Internet]. Bethesda: NIH; 2011 [updated 2012 November 5; cited 2013 April 10]. Available from:
  7. 7.
    Klitzman RL, Kleinert K, Rifai-Bashjawish H, Leu CS. The reporting of IRB review in journal articles presenting HIV research conducted in the developing world. Dev World Bioeth. 2011;11:161–9.PubMedCrossRefGoogle Scholar
  8. 8.
    Pasquali SK, Burstein DS, Benjamin DK Jr, Smith PB, Li JS. Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity. Pediatrics. 2010;126:e687–92.PubMedCrossRefGoogle Scholar
  9. 9.
    World Health Organization. Global HIV/AIDS response: epidemic update and health sector progress towards universal access: progress report 2011. Geneva, Switzerland; World Health Organization; 2011;18, 23, 24. ISBN 978 92 4 150298 6.Google Scholar
  10. 10.
    US National Institutes of Health [Internet]. Bethesda: NIH; [date unknown] [cited 2013 April 10]. Available from:
  11. 11.
    United Nations Statistics Division [Internet]. New York: United Nations; 2012 [updated 2013 February 11; cited 2013 April 10]. Available from:
  12. 12.
    US Food and Drug Administration [Internet]. Silver Spring: FDA; 2003 [updated 2009 May 22; cited 2013 April 10]. Available from:
  13. 13.
    Joint United Nations Programme on HIV/AIDS [Internet]. Geneva: UNAIDS; 2012 [cited 2013 April 10]. Available from: ISBN 978-92-9173-592-1.
  14. 14.
    US Food and Drug Administration [Internet]. Silver Spring: FDA; 2013 [cited 2013 April 10]. Available from:
  15. 15.
    Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Internet]. [Place unknown]: ICMJE; 2004 [cited 2013 April 10]. Available from:
  16. 16.
    US Food and Drug Administration [Internet]. Silver Spring: FDA; 2005 [updated 2010 January 8; cited 2013 April 10]. Available from:
  17. 17.
    Huser V, Cimino JJ. Evaluation adherence to the International Committee of Medical Journal Editors’ policy of mandatory, timely clinical trial registration. J Am Med Inform Assoc. 2013;0:1–6.Google Scholar

Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2013

Authors and Affiliations

  • Katie J. Suda
    • 1
    Email author
  • Jodie Greene
    • 1
  • Chasity M. Shelton
    • 1
  1. 1.University of Tennessee Health Science CenterMemphisUSA

Personalised recommendations