Optimizing Research to Speed Up Availability of Pediatric Antiretroviral Drugs and Formulations

Clin Infect Dis. 2017 Jun 1;64(11):1597-1603. doi: 10.1093/cid/cix194.


Globally 1.8 million children are living with human immunodeficiency virus (HIV), yet only 51% of those eligible actually start treatment. Research and development (R&D) for pediatric antiretrovirals (ARVs) is a lengthy process and lags considerably behind drug development in adults. Providing safe, effective, and well-tolerated drugs for children remains critical to ensuring scale-up globally. We review current approaches to R&D for pediatric ARVs and suggest innovations to enable simplified, faster, and more comprehensive strategies to develop optimal formulations. Several approaches could be adopted, including focusing on a limited number of prioritized formulations and strengthening existing partnerships to ensure that pediatric investigation plans are developed early in the drug development process. Simplified and more efficient mechanisms to undertake R&D need to be put in place, and financing mechanisms must be made more sustainable. Lessons learned from HIV should be shared to support progress in developing pediatric formulations for other diseases, including tuberculosis and viral hepatitis.

Keywords: HIV; antiretrovirals; children; formulations; research.

Publication types

  • Review

MeSH terms

  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / therapeutic use
  • Anti-Retroviral Agents / administration & dosage
  • Anti-Retroviral Agents / therapeutic use*
  • Child
  • Drug Approval / economics
  • Drug Approval / methods*
  • Drug Approval / organization & administration
  • Drug Combinations
  • Drug Compounding
  • HIV Infections / drug therapy
  • Humans
  • Research Support as Topic


  • Anti-HIV Agents
  • Anti-Retroviral Agents
  • Drug Combinations