Raltegravir Kaletra Pharmacokinetics (RAL-KAL)
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects of the pharmacokinetic interaction between raltegravir and Kaletra.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults|
- drug levels of lopinavir, ritonavir, raltegravir [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- safety [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Experimental: single arm
all subjects dosed the same
Drug: Raltegravir, lopinavir, ritonavir
4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period.
This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female subjects. The initial cohort, to be studied simultaneously, will be 15 subjects with intention to collect complete data from 12 subjects. Replacements will be subsequently enrolled if necessary. Subjects will be reimbursed.
The periods will be
- Period 1: Raltegravir (RAL) 400 mg q12h for 4 days (7 doses of RAL).
- Period 2: Kaletra 200 mg 2 pills bid for 10 days (19 doses of Kaletra).
- Period 3: both regimens for 4 days (7 doses of both drugs). All morning doses will be observed at Prism Research, Inc. Evening doses will be distributed each morning. 12 hour PK studies will be done on the last day of each period. Specimens will be obtained 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours after the morning dose of the last dosing day of each period.
|United States, Minnesota|
|Prism Research Inc|
|St Paul, Minnesota, United States, 55114|
|Principal Investigator:||Frank S Rhame, MD||Allina Hospitals & Clinics|