Conclusion

The Working Group has attempted to provide information specific to the use of antiretroviral drugs in infants, children, and adolescents while not duplicating the information available in antiretroviral recommendations for adults (5). Documents addressing recommendations for adults should be reviewed for basic information regarding disease pathogenesis and drug interactions. Although the general principles of therapy are the same for HIV-infected adults, adolescents, children, and infants, treatment of infection in pediatric patients requires an understanding of the unique aspects of HIV infection in children. Clinical trials of antiretroviral agents in HIV-infected children and the development of drug formulations appropriate for administration to children have often been delayed until after clinical trials in infected adults have been completed and/or the drug has been approved for use among infected adults. However, despite these delays, the paucity of pediatric-specific data cannot further deter the development of rational and reasonable pediatric treatment guidelines while studies in children are being undertaken. To maximize therapeutic options for HIV-infected pediatric patients throughout the course of their infection, drug formularies should facilitate the use of all FDA-approved antiretroviral agents as treatment options for children. Additionally, the conduct of clinical trials to define the pharmacokinetics, safety, and effectiveness in ameliorating the pediatric-specific manifestations of HIV infection of current and new antiretroviral agents is a priority; studies of new drugs should be conducted coincident with or soon after initial studies have been completed in adults. The Working Group will revise these guidelines as new data regarding antiretroviral therapy for infected infants, children, and adolescents become available.

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