Research concerning the treatment and prevention of HIV infection and disease and its sequelae in children, adolescents, and women (both pregnant and non-pregnant) must necessarily take into account the unique biomedical makeup and problems of these groups. Therefore, studies to evaluate the pharmacokinetics and safety of new drugs in children and pregnant women, including metabolic and short- and long-term effects of exposure, are critical to ensure appropriate use and approval of the drugs for these populations. The PAMA Branch is uniquely positioned to explore this research area because the NICHD is leading NIH-wide activities for the Best Pharmaceuticals for Children Act, and because of the NICHD's newly established Obstetric-Fetal Research Network, which directly addresses such topics in populations without HIV infection.

In addition, the field of HIV/AIDS research would benefit from the following types of studies:

• Identifying, both domestically and internationally, optimal strategies for timing of initiation of therapy in infants, children, and adolescents; when to change therapy; optimal treatments for those failing antiretroviral therapy; and therapies that improve the clinical status, quality of life, and survival of HIV-infected infants, children, and adolescents at all stages of disease, such as antiretroviral drugs, therapies aimed at immune reconstitution and use of therapeutic HIV vaccines
• Identifying therapies or prophylactic regimens that prevent or mitigate the development of serious sequelae of pediatric and adolescent HIV infection, such as including opportunistic infections, growth abnormalities, neurologic and neurodevelopmental impairments, and other complications of HIV
• Evaluating therapies to treat women-specific manifestations of HIV

In spite of the successes in the United States and Europe in reducing mother-to-child transmission of HIV infection, the need to address this issue domestically still exists, and the need to address the problem internationally is growing. Additional possible types of studies related to this area include:

• Evaluating interventions to further reduce mother to child HIV transmission, particularly for women identified as HIV-infected very late in pregnancy or at labor who therefore have not received antiretroviral therapy
• Establishing interventions to reduce transmission of HIV through breast milk in the developing world
• Understanding the long-term implications of limited antiretroviral therapy (during pregnancy for preventing mother-to-child HIV transmission) on maternal health and subsequent response to therapy to allow development of optimal regimens for both prevention and treatment