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A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01000818
First received: October 22, 2009
Last updated: February 14, 2017
Last verified: February 2017
October 22, 2009
February 14, 2017
June 2008
March 2009   (Final data collection date for primary outcome measure)
Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir [ Time Frame: 12 hours postdose ]
Area Under the Plasma Concentration-Time Curve and peak concentration
AUC(0-12) of MK0518 after coadministration of MK0518 and omeprazole compared to AUC(0-12) after administration of MK0518 alone [ Time Frame: 12 hours postdose ]
Complete list of historical versions of study NCT01000818 on ClinicalTrials.gov Archive Site
Not Provided
AUC(0-12) of MK0518 after coadministration of MK0518 and famotidine compared to AUC(0-12) after administration of MK0518 alone [ Time Frame: 12 hours postdose ]
Not Provided
Not Provided
 
A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
An Open-Label, 3-Period, Fixed-Sequence Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 Pharmacokinetics in HIV-Infected Patients on a Stable MK0518-Containing Regimen
An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV-1 Infection
  • HIV Infections
  • Drug: MK0518 (Raltegravir)
    400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.
    Other Name: Raltegravir
  • Drug: famotidine
    Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
  • Drug: omeprazole
    20 mg oral tablet of omeprazole, once daily for 5 days
  • Experimental: Period 1
    MK0518
    Intervention: Drug: MK0518 (Raltegravir)
  • Experimental: Period 2
    famotidine + MK0518
    Interventions:
    • Drug: MK0518 (Raltegravir)
    • Drug: famotidine
  • Experimental: Period 3
    omeprazole + MK0518
    Interventions:
    • Drug: MK0518 (Raltegravir)
    • Drug: omeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is Human immunodeficiency virus (HIV) positive
  • Patient is taking an MK0518 (Raltegravir) containing regimen
  • Patient has not had any changes to his/her antiviral regimen in the last 2 weeks
  • Patient who is of reproductive potential agrees to use an acceptable method of birth control
  • Patients baseline health is stable

Exclusion Criteria:

  • Patient has a history of stroke or chronic seizures.
  • Patient has a history of gastric bypass surgery
  • Patient is pregnant of breastfeeding
  • Patient consumes excessive amounts of caffeinated beverages daily
  • Patient has had major surgery, donated blood, or participated in another investigational study in the past 4 weeks
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01000818
0518-054
MK0518-054
2009_681
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2017

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