Raltegravir Kaletra Pharmacokinetics

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allina Health System; Allina Hospitals and Clinics
• Treatments: Lopinavir; Raltegravir Potassium; Ritonavir

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.