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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:
ClinicalTrials.gov Identifier:
NCT01930045
First Posted: August 28, 2013
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: October 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir (ISENTRESS™)
Drug: MAALOX (MAL)

  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
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.7  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  22.2% 
Male      14  77.8% 


  Outcome Measures
  Show All Outcome Measures

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
No text entered.


  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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01930045     History of Changes
Other Study ID Numbers: 0518-295
First Submitted: August 23, 2013
First Posted: August 28, 2013
Results First Submitted: October 29, 2014
Results First Posted: November 3, 2014
Last Update Posted: March 21, 2017