Raltegravir Kaletra Pharmacokinetics (RAL-KAL)

Allina Health System

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: Raltegravir, lopinavir, ritonavir

Study type

Interventional

Funder types

Other

Identifiers

NCT00564772

FDA IND No. 78958

78958

Prism Research No. 714

Allina IRB No. 2366-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.