NCT00564772

Raltegravir Kaletra Pharmacokinetics

An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Allina Health System · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-11-28
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States