PACTG 1058

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The study, entitled Intensive Pharmacokinetic Studies of Antiretroviral Drug Combinations in Children is an intensive 12-hour pharmacokinetic study of selected antiretroviral drugs in Human Immunodeficiency Virus (HIV)-infected children who are receiving or about to initiate a regimen of antiretrovirals that includes one of three drug combinations of non-nucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI). These combinations include drugs that may not be labeled for marketing for use in children (for example saquinavir {Invirase). The optimal dosages or combination of dosages may not be known for the pediatric population. .Labeling information cannot be determined until more pharmacokinetic information has been collected and analyzed. Despite this limited information, the current Centers for Disease Control (CDC) Pediatric HIV Treatment Guidelines allows use of these medications; and more importantly, there are times when a child's individual viral load and resistance profile (genotype and phenotype) clinically indicates the use of these combinations. Therefore it is vital to obtain better information about the pharmacokinetics of these combinations currently in use by today's pediatric infectious disease specialists. This information will ultimately lead to more appropriate and effective dosing for the pediatric and adolescent population, as well as the subjects who participate in this protocol.