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A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01930045
First received: August 23, 2013
Last updated: October 29, 2014
Last verified: October 2014
Results First Received: October 29, 2014  
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 (ISENTRESS™)
Drug: MAALOX (MAL)

  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
No text entered.

Reporting Groups
  Description
Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5

Participant Flow for 6 periods

Period 1:   Part 1 - Period 1
    Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL     MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL     Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL     Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt     MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt     Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt  
STARTED     3     3     3     3     3     3  
COMPLETED     3     3     3     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Part 1 - Period 2
    Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL     MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL     Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL     Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt     MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt     Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt  
STARTED     3     3     3     3     3     3  
COMPLETED     3     3     3     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Part 1 - Period 3
    Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL     MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL     Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL     Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt     MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt     Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt  
STARTED     3     3     2 [1]   3     3     3  
COMPLETED     3     3     2     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  
[1] One participant missed treatment during Period 3 only.

Period 4:   Pause (up to 37 Days)
    Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL     MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL     Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL     Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt     MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt     Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt  
STARTED     3     3     3 [1]   3     3     3  
COMPLETED     3     3     3     3     3     1  
NOT COMPLETED     0     0     0     0     0     2  
Withdrawal by Subject                 0                 0                 0                 0                 0                 1  
Protocol Violation                 0                 0                 0                 0                 0                 1  
[1] The participant who missed treatment in Period 3, resumed the study

Period 5:   Part 2 - Period 4
    Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL     MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL     Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL     Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt     MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt     Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt  
STARTED     3     3     3     3     3     1  
COMPLETED     3     3     3     3     3     1  
NOT COMPLETED     0     0     0     0     0     0  

Period 6:   Part 2 - Period 5
    Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL     MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL     Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL     Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt     MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt     Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt  
STARTED     3     3     3     3     3     1  
COMPLETED     3     3     3     3     3     1  
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.
No text entered.

Reporting Groups
  Description
All Participants All enrolled participants

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  18  
Age  
[units: Years]
Mean ± Standard Deviation
  48.7  ± 9.0  
Gender  
[units: Participants]
 
Female     4  
Male     14  



  Outcome Measures
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1.  Primary:   Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1   [ Time Frame: 12 hours after dosing on Day 1 of each period ]

2.  Primary:   Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1   [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period ]

3.  Primary:   Maximum Plasma Concentration (C Max) of Raltegravir in Part 1   [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period ]

4.  Primary:   Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2   [ Time Frame: 12 hours after dosing on Day 1 of each period ]

5.  Primary:   Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2   [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period ]

6.  Primary:   Maximum Plasma Concentration (C Max) of Raltegravir in Part 2   [ Time Frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period ]


  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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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01930045     History of Changes
Other Study ID Numbers: 0518-295
Study First Received: August 23, 2013
Results First Received: October 29, 2014
Last Updated: October 29, 2014
Health Authority: United States: Food and Drug Administration