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An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects

NCT00802074 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-01-29

Study results available
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Summary

To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL112775 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, fasting, HIV-negative adults after administration of a 7-day regimen of RTG 400mg BID alone and after 14-day regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/RTV 100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent RTG 400mg BID. Blood samples for drug concentration measurement will be collected over 12 hours at the end of each dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and adherence (by pill count and medication diary) will be assessed by the investigator/study personnel at the end of each dosing period

Conditions

  • Healthy

Interventions

DRUG

Raltegravir

400mg BID

DRUG

Fosamprenavir

1400mg BID, 700 mg BID or 1400 mg QD

DRUG

Ritonavir

100 mg BID or QD

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Garden State Infectious Disease Associates, PA

    lead OTHER

Principal Investigators

  • David V Condoluci, DO · GSIDA

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00802074 on ClinicalTrials.gov