Raltegravir Kaletra Pharmacokinetics - Full Text View

Sponsored by:	Allina Hospitals and Clinics
Information provided by:	Allina Hospitals and Clinics
ClinicalTrials.gov Identifier:	NCT00564772

Purpose

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	Intervention	Phase
Healthy	Drug: Raltegravir, lopinavir, ritonavir	Phase IV

Drug Information available for: Ritonavir Raltegravir Lopinavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults

Further study details as provided by Allina Hospitals and Clinics:

Primary Outcome Measures:

drug levels of lopinavir, ritonavir, raltegravir [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment:	15
Study Start Date:	November 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single arm: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564772

Locations

United States, Minnesota
Prism Research Inc
St Paul, Minnesota, United States, 55114

Sponsors and Collaborators

Allina Hospitals and Clinics

Investigators

Principal Investigator:

Frank S Rhame, MD

Allina Hospitals & Clinics

More Information

Responsible Party:	Allina Health System ( Frank Rhame )
Study ID Numbers:	78958, Allina IRB No. 2366-1, Prism Research No. 714, FDA IND No. 78958
Study First Received:	November 27, 2007
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00564772
Health Authority:	United States: Food and Drug Administration

Keywords provided by Allina Hospitals and Clinics:

raltegravir
lopinavir
ritonavir
pharmacokinetics

Study placed in the following topic categories:

Lopinavir
Ritonavir
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009