Pediatric Subcommittee

of the

Anti-Infective Drugs Advisory Committee

03 March 2003

Questions for the Committee


  1. Since neonates born to HIV-infected mothers may be tested for HIV infection in the first 48 hours and at 4 weeks, HIV-infected infants can be diagnosed as early as one month of age. The U.S. Public Health Service guidelines recommend treating HIV-infected infants less than one year of age with combination antiretroviral as soon as possible after diagnosis. All HIV-exposed infants are treated with prophylactic antiretroviral(s) for six weeks after birth.
  1. Given that an estimated 300 to 400 HIV-infected infants are born annually each year in the United States, that some of these infants are diagnosed after the first several months of life, and that it is difficult to enroll neonates in studies,
  1. Should we continue to request pharmacokinetic and safety studies for every antiretroviral drug under development?
  2. If not: