Overview

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.