RAL-KAL: Raltegravir Kaletra Pharmacokinetics

Sponsor

Allina Health System (Other)

Overall Status

Completed

CT.gov ID

NCT00564772

Collaborator

(none)

Enrollment

Location

Arm

Duration (Days)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Raltegravir, lopinavir, ritonavir	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single arm all subjects dosed the same	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. Other Names: Isentress Kaletra

Arm

Intervention/Treatment

Experimental: single arm

all subjects dosed the same

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.

Other Names:

Isentress

Kaletra

Outcome Measures

Primary Outcome Measures

drug levels of lopinavir, ritonavir, raltegravir [2 months]

Secondary Outcome Measures

safety [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.