Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study.
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3
clinical development for the treatment of HIV infection. As HIV-infected subjects may also be
receiving methadone for opioid dependence, an evaluation of the potential interaction between
DTG and methadone is warranted. The primary objective of this study is to determine whether
concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone. As a
secondary endpoint, the PK of DTG will be compared to historical data. This study will be
open-label with subjects receiving DTG and stable doses of methadone. The study will be
conducted at one center in Canada in adult male and female subjects.