An Interaction Study to Assess Drug Levels in Healthy Adult Subjects
Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
To date, no study has investigated whether there is a drug interaction between the protease
inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL111242 is a randomized,
open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir
(APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, HIV-negative adults after
administration of a 7-day regimen of RTG 400mg twice a day (BID) alone and after 14-day
regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/Ritonavir (RTV)
100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent
RTG 400mg BID. Blood samples for drug concentration measurement will be collected over 12
hours at the end of each dosing period. Subjects will undergo a physical examination,
complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function
test, renal function analysis, and lipid panel at screening, and all of these tests, except
those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and
adherence (by pill count and medication diary) will be assessed by the investigator/study
personnel at the end of each dosing period