METHADONE QD WITH FOSAMPRENAVIR

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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. This is an open label study to look at the combined effects of Fosamprenavir 700mg BID + Ritonavir 100mg BID, on blood levels of Methadone and Methadone effects in subjects on Methadone maintenance. This is an important question as HIV infected individuals some of whom are on methadone maintenance, will be treated with FPV and RTV for their HIV infection. We need to understand possible interactions of these medicines. HIV seronegative subjects enrolled in a certified methadone maintenance program for at least 12 weeks and who have been maintained on a stable methadone QD dosage regimen for 30 days prior to receiving study drug will be enrolled. Subjects will receive methadone QD at the study center during Period 1, Days 1-4. Subjects will undergo serial plasma PK sampling and opiate PD measurements on Period 1, Day 4, prior to and following administration of methadone. Following collection of the last 24-hour plasma methadone PK sample, Period 2 begins. On Period 2, Day 1, subjects will initiate dosing of methadone QD in combination with FPV 700mg BID + RTV 100mg BID and will continue this regimen through Period 2, Day 14. Subjects will undergo serial plasma PK sampling on Period 2, Day 14 and opiate PD measures on Period 2, Days 7 and 14. Throughout the study, safety will be assessed through adverse event, concurrent medication, clinical laboratory, and vital signs assessments. Subjects will return to the clinic for a follow-up visit 14-21 days following discontinuation of study drugs.