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Raltegravir Kaletra Pharmacokinetics (RAL-KAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00564772
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : March 20, 2019
Information provided by (Responsible Party):
Allina Health System

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. drug levels of lopinavir, ritonavir, raltegravir [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. safety [ Time Frame: 2 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00564772

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United States, Minnesota
Prism Research Inc
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Allina Health System
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Principal Investigator: Frank S Rhame, MD Allina Hospitals & Clinics
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Responsible Party: Allina Health System Identifier: NCT00564772    
Other Study ID Numbers: 78958
Allina IRB No. 2366-1
Prism Research No. 714
FDA IND No. 78958
First Posted: November 28, 2007    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Keywords provided by Allina Health System:
Additional relevant MeSH terms:
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Raltegravir Potassium
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors