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: May 29, 2014
Last verified: May 2014
Results First Received: March 10, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV-1 Infection
HIV Infections
Interventions: Drug: MK0518 (Raltegravir)
Drug: famotidine
Drug: omeprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited through Abbott Northwestern Hospital Infectious Diseases Clinic, Minneapolis, MN and Prism Research, St. Paul, MN, between June 2008 and March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 18 participants were enrolled in the study.

Reporting Groups
  Description
Raltegravir/Famotidine/Omeprazole

Period 1 - 400 mg Raltegravir x 1 day

Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day

Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days


Participant Flow for 3 periods

Period 1:   Raltegravir
    Raltegravir/Famotidine/Omeprazole  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  

Period 2:   Famotidine + Raltegravir
    Raltegravir/Famotidine/Omeprazole  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  

Period 3:   Omeprazole + Raltegravir
    Raltegravir/Famotidine/Omeprazole  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Raltegravir/Famotidine/Omeprazole

Period 1 - 400 mg Raltegravir x 1 day

Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day

Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days


Baseline Measures
    Raltegravir/Famotidine/Omeprazole  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean ( Full Range )
  49.3  
  ( 37 to 59 )  
Gender  
[units: participants]
 
Female     2  
Male     16  
Height  
[units: Centimeters]
Mean ( Full Range )
  176.6  
  ( 161.0 to 188.0 )  
Weight  
[units: Kilograms]
Mean ( Full Range )
  85.7  
  ( 60.6 to 141.0 )  



  Outcome Measures

1.  Primary:   Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir   [ Time Frame: 12 hours postdose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information