A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000818
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : May 28, 2010
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (37 to 59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      2  11.1% 
Male      16  88.9% 
[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

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