The past two decades of fighting the HIV/AIDS epidemic has led to an explosion of therapies developed to limit viral replication or to combat the complications of HIV infection. More antiviral agents are licensed and available to treat HIV than any other viral infection. In the USA, 20 drugs are currently approved in adults for use in HIV infection and 12 have pediatric label information. These approvals are the result of hundreds of clinical studies performed in adults and children through collaborations of clinical investigators, industry, and government partners to support drug development. All too frequently, clinicians find that drugs approved for use in adults or some pediatric populations have insufficient dosing information for their younger patients. Pediatricians know that children are not just small adults. Typically dose recommendations for children are not obtained by simply scaling an adult dose by weight. Additionally, potential risks may well be different in a child that is growing and developing. As a result we have a critical need to conduct clinical studies in children to ensure that they too have the potential to benefit from drug discoveries that are of benefit to older patient populations. It is well recognized though, that children, since they are not able to consent for research themselves, are a population that warrant special protections. Thus, clinical trials in pediatric populations are conducted with due caution for the child's safety while being balanced with moving forward as quickly as possible to open new treatment options.