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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)

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ClinicalTrials.gov Identifier: NCT01000818
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : May 28, 2010
Last Update Posted : March 21, 2017
Sponsor:
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
Enrollment 18

Recruitment Details 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 A total of 18 participants were enrolled in the study.
Arm/Group Title Raltegravir/Famotidine/Omeprazole
Hide Arm/Group Description

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

Period Title: Raltegravir
Started 18
Completed 18
Not Completed 0
Period Title: Famotidine + Raltegravir
Started 18
Completed 18
Not Completed 0
Period Title: Omeprazole + Raltegravir
Started 18
Completed 18
Not Completed 0
Arm/Group Title Raltegravir/Famotidine/Omeprazole
Hide Arm/Group Description

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

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
49.3
(37 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
2
  11.1%
Male
16
  88.9%
Height  
Mean (Full Range)
Unit of measure:  Centimeters
Number Analyzed 18 participants
176.6
(161.0 to 188.0)
Weight  
Mean (Full Range)
Unit of measure:  Kilograms
Number Analyzed 18 participants
85.7
(60.6 to 141.0)
1.Primary Outcome
Title Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
Hide Description Area Under the Plasma Concentration-Time Curve and peak concentration
Time Frame 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eighteen HIV-Infected Patients
Arm/Group Title 400 mg Raltegravir 20 mg Famotidine + 400 mg Raltegravir 20 mg Omeprazole + 400 mg Raltegravir
Hide Arm/Group Description:
Period 1 - 400 mg Raltegravir
Period 2 - 20 mg Famotidine + 400 mg Raltegravir
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
Overall Number of Participants Analyzed 18 18 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: µM*hr
12.36
(8.96 to 17.04)
17.95
(13.02 to 24.75)
17.12
(12.42 to 23.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 400 mg Raltegravir, 20 mg Omeprazole + 400 mg Raltegravir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.39
Confidence Interval 95%
1.04 to 1.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 400 mg Raltegravir, 20 mg Famotidine + 400 mg Raltegravir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.45
Confidence Interval 95%
1.09 to 1.93
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prestudy 400 mg Raltegravir 20 mg Famotidine + 400 mg Raltegravir 20 mg Omeprazole + 400 mg Raltegravir
Hide Arm/Group Description [Not Specified] Period 1 - 400 mg Raltegravir Period 2 - 20 mg Famotidine + 400 mg Raltegravir Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
All-Cause Mortality
Prestudy 400 mg Raltegravir 20 mg Famotidine + 400 mg Raltegravir 20 mg Omeprazole + 400 mg Raltegravir
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prestudy 400 mg Raltegravir 20 mg Famotidine + 400 mg Raltegravir 20 mg Omeprazole + 400 mg Raltegravir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Cardiac disorders         
Ruptured coronary artery plaque * 1  1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prestudy 400 mg Raltegravir 20 mg Famotidine + 400 mg Raltegravir 20 mg Omeprazole + 400 mg Raltegravir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      2/18 (11.11%)      1/18 (5.56%)      6/18 (33.33%)    
Gastrointestinal disorders         
Abnormal feces * 1  0/18 (0.00%)  0 0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Constipation * 1  0/18 (0.00%)  0 0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Gastrooesophageal reflux disease * 1  0/18 (0.00%)  0 0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
vomiting * 1  0/18 (0.00%)  0 2/18 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications         
Excoriation * 1  0/18 (0.00%)  0 0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Investigations         
Electrocardiogram QT prolonged * 1  0/18 (0.00%)  0 0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders         
Knee pain * 1  0/18 (0.00%)  0 0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Nervous system disorders         
Headache * 1  0/18 (0.00%)  0 1/18 (5.56%)  1/18 (5.56%)  0/18 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
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 SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01000818     History of Changes
Other Study ID Numbers: 0518-054
MK0518-054
2009_681
First Submitted: October 22, 2009
First Posted: October 23, 2009
Results First Submitted: March 10, 2010
Results First Posted: May 28, 2010
Last Update Posted: March 21, 2017