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

November 27, 2007
June 16, 2008
November 2007
December 2007   (final data collection date for primary outcome measure)
drug levels of lopinavir, ritonavir, raltegravir [ Time Frame: 2 months ] [ Designated as safety issue: No ]
drug levels of lopinavir, ritonavir, raltegravir [ Time Frame: 2 months ]
Complete list of historical versions of study NCT00564772 on ClinicalTrials.gov Archive Site
safety [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
safety [ Time Frame: 2 months ]
Not Provided
Not Provided
 
Raltegravir Kaletra Pharmacokinetics
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.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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
Experimental: single arm
all subjects dosed the same
Intervention: Drug: Raltegravir, lopinavir, ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00564772
78958, Allina IRB No. 2366-1, Prism Research No. 714, FDA IND No. 78958
No
Frank Rhame, Allina Health System
Allina Hospitals and Clinics
Not Provided
Principal Investigator: Frank S Rhame, MD Allina Hospitals & Clinics
Allina Hospitals and Clinics
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP