Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 22, 2009
Last updated: November 25, 2014
Last verified: November 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

  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.
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Reporting Groups

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
Number of Participants  
[units: participants]
[units: years]
Mean ( Full Range )
  ( 37 to 59 )  
[units: participants]
Female     2  
Male     16  
[units: Centimeters]
Mean ( Full Range )
  ( 161.0 to 188.0 )  
[units: Kilograms]
Mean ( Full Range )
  ( 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
  Hide 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
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  More Information