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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:
ClinicalTrials.gov Identifier:
NCT01000818
First Posted: October 23, 2009
Last Update Posted: March 21, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: 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
  Hide Participant Flow

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 
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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Prestudy No text entered.
400 mg Raltegravir Period 1 - 400 mg Raltegravir
20 mg Famotidine + 400 mg Raltegravir Period 2 - 20 mg Famotidine + 400 mg Raltegravir
20 mg Omeprazole + 400 mg Raltegravir Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days

Other Adverse Events
    Prestudy   400 mg Raltegravir   20 mg Famotidine + 400 mg Raltegravir   20 mg Omeprazole + 400 mg Raltegravir
Total, Other (not including serious) Adverse Events         
# participants affected / at risk   0/18 (0.00%)   2/18 (11.11%)   1/18 (5.56%)   6/18 (33.33%) 
Gastrointestinal disorders         
Abnormal feces * 1         
# participants affected / at risk   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   1/18 (5.56%) 
# events   0          
Constipation * 1         
# participants affected / at risk   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   1/18 (5.56%) 
# events   0          
Gastrooesophageal reflux disease * 1         
# participants affected / at risk   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   1/18 (5.56%) 
# events   0          
vomiting * 1         
# participants affected / at risk   0/18 (0.00%)   2/18 (11.11%)   0/18 (0.00%)   0/18 (0.00%) 
# events   0          
Injury, poisoning and procedural complications         
Excoriation * 1         
# participants affected / at risk   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   1/18 (5.56%) 
# events   0          
Investigations         
Electrocardiogram QT prolonged * 1         
# participants affected / at risk   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   1/18 (5.56%) 
# events   0          
Musculoskeletal and connective tissue disorders         
Knee pain * 1         
# participants affected / at risk   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   1/18 (5.56%) 
# events   0          
Nervous system disorders         
Headache * 1         
# participants affected / at risk   0/18 (0.00%)   1/18 (5.56%)   1/18 (5.56%)   0/18 (0.00%) 
# events   0          
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 12.1



  Limitations and Caveats
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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