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Raltegravir Kaletra Pharmacokinetics (RAL-KAL)

This study has been completed.
Sponsor:
Information provided by:
Allina Hospitals and Clinics
ClinicalTrials.gov Identifier:
NCT00564772
First received: November 27, 2007
Last updated: June 16, 2008
Last verified: June 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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
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

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

No publications provided

Responsible Party: Frank Rhame, Allina Health System
ClinicalTrials.gov Identifier: NCT00564772     History of Changes
Other 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Allina Hospitals and Clinics:
raltegravir
lopinavir
ritonavir
pharmacokinetics

Additional relevant MeSH terms:
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013