Raltegravir Kaletra Pharmacokinetics

Completed · Phase 4

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00564772

Run by

Allina Health System

People needed

15

Starts

2007-11-01

Expected to finish

2007-12-01

Last updated by the study team

2019-03-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, male or female, age 18-55.
• Anti-HIV, anti-HCV, HBsAg negative.
• Normal history and physical at screening.
• Normal complete blood count, creatinine and ALT at screening.
• Negative urine pregnancy test at screening.
• BMI 18-30.

You may not qualify if…

• Donated blood in the month before Day 1.
• Participated in another research study in the month before Day 1.
• Tobacco use in the 3 months before Day 1, unwillingness to avoid tobacco use during the study.
• Use of any illegal drug in the year before Day 1, positive drug screen for an illegal drug at screening.
• Unwillingness to restrict coffee use to 6 or fewer cups of coffee during the study.
• Unwillingness on the part of fertile female subjects to be abstinent or to use two effective birth control methods, one of which is a barrier method, for any vaginal intercourse.
• Unwillingness to avoid use of any prescribed medication during the study
• Allergy to RAL, lopinavir or ritonavir.

Where it is running

• Prism Research Inc — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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