Raltegravir Kaletra Pharmacokinetics

NCT ID: NCT00564772

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2007-12-31

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

all subjects dosed the same

Group Type: EXPERIMENTAL

Raltegravir, lopinavir, ritonavir

Intervention Type: DRUG

4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Isentress; Kaletra

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allina Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank S Rhame, MD

Role: PRINCIPAL_INVESTIGATOR

Allina Hospitals & Clinics

Locations

Prism Research Inc

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

Allina IRB No. 2366-1

Identifier Type: -

Identifier Source: secondary_id

Prism Research No. 714

Identifier Type: -

Identifier Source: secondary_id

FDA IND No. 78958

Identifier Type: -

Identifier Source: secondary_id

78958

Identifier Type: -

Identifier Source: org_study_id