Raltegravir Kaletra Pharmacokinetics (RAL-KAL)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Raltegravir, lopinavir, ritonavir

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Prism Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
drug levels of lopinavir, ritonavir, raltegravir	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
safety	2 months

Collaborators and Investigators

• Sponsor: Allina Health System
• Investigators: Principal Investigator: Frank S Rhame, MD, Allina Hospitals & Clinics

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: November 27, 2007
• First Submitted That Met QC Criteria: November 27, 2007
• First Posted (Estimate): November 28, 2007

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: pharmacokinetics; raltegravir; ritonavir; lopinavir
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Raltegravir Potassium; Ritonavir; Lopinavir
• Other Study ID Numbers: 78958; Allina IRB No. 2366-1; Prism Research No. 714; FDA IND No. 78958