An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects
Status:
Completed
Trial end date:
2009-04-01
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. COL112775 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, fasting, HIV-negative adults
after administration of a 7-day regimen of RTG 400mg BID alone and after 14-day regimens of
unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/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