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Sponsored by: |
Allina Hospitals and Clinics |
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Information provided by: | Allina Hospitals and Clinics |
ClinicalTrials.gov Identifier: | NCT00564772 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults |
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 |
---|---|
single arm: Experimental
all subjects dosed the same
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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.
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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
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Prism Research Inc | |
St Paul, Minnesota, United States, 55114 |
Principal Investigator: | Frank S Rhame, MD | Allina Hospitals & Clinics |
Responsible Party: | Allina Health System ( Frank Rhame ) |
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 |
ClinicalTrials.gov Identifier: | NCT00564772 |
Health Authority: | United States: Food and Drug Administration |
raltegravir lopinavir ritonavir pharmacokinetics |
Lopinavir Ritonavir Healthy |
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors |