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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)

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ClinicalTrials.gov Identifier: NCT01000818
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : May 28, 2010
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 23, 2009
Results First Submitted Date  ICMJE March 10, 2010
Results First Posted Date  ICMJE May 28, 2010
Last Update Posted Date March 21, 2017
Study Start Date  ICMJE June 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV-1 Infection
  • HIV Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2009)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000818
Other Study ID Numbers  ICMJE 0518-054
MK0518-054
2009_681
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date February 2017

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