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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01000818
First received: October 22, 2009
Last updated: May 3, 2010
Last verified: May 2010
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


  Baseline Characteristics
  Hide Baseline Characteristics

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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01000818     History of Changes
Other Study ID Numbers: 2009_681, MK0518-054
Study First Received: October 22, 2009
Results First Received: March 10, 2010
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration