A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01622673
First received: June 15, 2012
Last updated: March 7, 2014
Last verified: March 2014
Results First Received: July 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir
Drug: TUMS® Ultra Strength
Drug: MINTOX® Maximum Strength

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.

Participant Flow for 5 periods

Period 1:   Treatment Period 1
    RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL     TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL     MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL     RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL     TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL     MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL  
STARTED     4     5     4     6     4     4  
COMPLETED     4     4     4     5     4     4  
NOT COMPLETED     0     1     0     1     0     0  
Withdrawal by Subject                 0                 0                 0                 1                 0                 0  
Protocol Violation                 0                 1                 0                 0                 0                 0  

Period 2:   Treatment Period 2
    RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL     TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL     MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL     RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL     TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL     MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL  
STARTED     4     4     4     5     4     4  
COMPLETED     4     4     4     4     4     4  
NOT COMPLETED     0     0     0     1     0     0  
Withdrawal by Subject                 0                 0                 0                 1                 0                 0  

Period 3:   Treatment Period 3
    RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL     TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL     MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL     RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL     TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL     MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL  
STARTED     4     4     4     4     4     4  
COMPLETED     4     3     4     4     4     4  
NOT COMPLETED     0     1     0     0     0     0  
Protocol Violation                 0                 1                 0                 0                 0                 0  

Period 4:   Treatment Period 4
    RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL     TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL     MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL     RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL     TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL     MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL  
STARTED     4     3     4     4     4     4  
COMPLETED     4     3     4     4     4     4  
NOT COMPLETED     0     0     0     0     0     0  

Period 5:   Treatment Period 5
    RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL     TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL     MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL     RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL     TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL     MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL  
STARTED     4     3     4     4     4     4  
COMPLETED     4     3     4     4     4     4  
NOT COMPLETED     0     0     0     0     0     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.
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Reporting Groups
  Description
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
Total Total of all reporting groups

Baseline Measures
    RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL     TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL     MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL     RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL     TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL     MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL     Total  
Number of Participants  
[units: participants]
  4     5     4     6     4     4     27  
Age  
[units: years]
Mean ± Standard Deviation
  42.5  ± 10.4     46.6  ± 9.5     36.8  ± 15.4     40.3  ± 10.3     39.8  ± 11.8     40.8  ± 11.6     41.3  ± 10.7  
Gender  
[units: participants]
             
Female     2     1     0     2     0     0     5  
Male     2     4     4     4     4     4     22  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)   [ Time Frame: 12 hours postdose ]

2.  Primary:   Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)   [ Time Frame: 12 hours postdose ]

3.  Primary:   Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

4.  Primary:   Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

5.  Primary:   Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

6.  Primary:   Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

7.  Primary:   Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

8.  Primary:   Number of Participants With Any Clinical or Laboratory Adverse Event (AE)   [ Time Frame: Up to 7 days after the last dose of study drug ]


  Serious Adverse Events


  Other Adverse Events


  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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