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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
Results First Received: March 10, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
  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 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Mean (Full Range)
 49.3 
 (37 to 59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  11.1% 
Male      16  88.9% 
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
  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