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Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies
  1. Michelle Hume1,
  2. Linda L Lewis2,
  3. Robert M Nelson3
  1. 1Department of Psychiatry, University of Wisconsin, Madison, Wisconsin, USA
  2. 2Clinton Health Access Initiative, Boston, Massachusetts, USA
  3. 3Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland, USA
  1. Correspondence to Dr Robert M Nelson, Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, WO32–5152, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA; Robert.Nelson{at}fda.hhs.gov

Abstract

The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs in adolescents are expected to be similar to those in adults. Finally, adolescents enrolled in therapeutic HIV prevention and treatment research can be considered adults, based on US Food and Drug Administration (FDA) regulations and the appropriate application of state law. The FDA permits local jurisdictions to apply state and local HIV/sexually transmitted infection minor treatment laws so that adolescents who are HIV-positive or at risk of contracting HIV may be enrolled in therapeutic or prevention trials without obtaining parental permission.

  • Clinical trials
  • Children
  • HIV Infection and AIDS
  • Minors/Parental Consent
  • Research Ethics
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Footnotes

  • This work was performed while MH and LLL were employed by the US Food and Drug Administration.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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