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Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292) (onceMRK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02131233
First received: May 2, 2014
Last updated: May 17, 2017
Last verified: May 2017
History of Changes
Results First Received: September 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: Reformulated Raltegravir
Drug: Raltegravir
Drug: TRUVADA™
Drug: Placebo to Reformulated Raltegravir
Drug: Placebo to Raltegravir

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
These results stop at the primary data cutoff at Week 48

Reporting Groups
  Description
Reformulated Raltegravir Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
Raltegravir Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks

Participant Flow:   Overall Study
    Reformulated Raltegravir   Raltegravir
STARTED   533 [1]   269 [1] 
Treated   531   266 
COMPLETED   490 [2]   242 [2] 
NOT COMPLETED   43   27 
Not Treated                2                3 
Adverse Event                6                6 
Death                0                1 
Lack of Efficacy                4                1 
Lost to Follow-up                8                4 
Non-Compliance With Study Drug                5                4 
Physician Decision                4                0 
Pregnancy                2                0 
Withdrawal by Subject                12                8 
[1] Enrolled participants
[2] Completed to Week 48



  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.
All Treated Participants

Reporting Groups
  Description
Reformulated Raltegravir Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
Raltegravir Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
Total Total of all reporting groups

Baseline Measures
   Reformulated Raltegravir   Raltegravir   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 531   266   797 
Age 
[Units: Years]
Mean (Standard Deviation) 		 35.4  (10.3)   36.9  (11.0)   35.9  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      91  17.1%      32  12.0%      123  15.4% 
Male      440  82.9%      234  88.0%      674  84.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48   [ Time Frame: Week 48 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline and Week 48 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With an Adverse Event (AE) at Week 48   [ Time Frame: Up to Week 48 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With a Drug-Related AE at Week 48   [ Time Frame: Up to Week 48 ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants With a Serious Adverse Event (SAE) at Week 48   [ Time Frame: Up to Week 48 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With a Serious and Drug-Related AE at Week 48   [ Time Frame: Up to Week 48 ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48   [ Time Frame: Up to Week 48 ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Achieving <40 Copies/mL HIV-1 RNA at Week 96   [ Time Frame: Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

9.  Secondary:   Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline and Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

10.  Secondary:   Percentage of Participants With an AE at Week 96   [ Time Frame: Up to Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

11.  Secondary:   Percentage of Participants With a Drug-Related AE at Week 96   [ Time Frame: Up to Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

12.  Secondary:   Percentage of Participants With a SAE at Week 96   [ Time Frame: Up to Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

13.  Secondary:   Percentage of Participants With a Serious and Drug-Related AE at Week 96   [ Time Frame: Up to Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  

14.  Secondary:   Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 96   [ Time Frame: Up to Week 96 ]
Results not yet reported.   Anticipated Reporting Date:   12/2017  


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
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Time Frame Up to Week 48
Additional Description All randomized participants who received at least one dose of study treatment.

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

Reporting Groups
  Description
Reformulated Raltegravir Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
Raltegravir Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks

Other Adverse Events
    Reformulated Raltegravir   Raltegravir
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   261/531 (49.15%)   132/266 (49.62%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   40/531 (7.53%)   11/266 (4.14%) 
# events   49   14 
Diarrhoea † 1     
# participants affected / at risk   58/531 (10.92%)   30/266 (11.28%) 
# events   65   34 
Nausea † 1     
# participants affected / at risk   60/531 (11.30%)   26/266 (9.77%) 
# events   71   28 
Vomiting † 1     
# participants affected / at risk   35/531 (6.59%)   14/266 (5.26%) 
# events   36   16 
General disorders     
Fatigue † 1     
# participants affected / at risk   33/531 (6.21%)   16/266 (6.02%) 
# events   35   17 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   44/531 (8.29%)   22/266 (8.27%) 
# events   51   28 
Syphilis † 1     
# participants affected / at risk   13/531 (2.45%)   14/266 (5.26%) 
# events   13   14 
Upper respiratory tract infection † 1     
# participants affected / at risk   40/531 (7.53%)   19/266 (7.14%) 
# events   49   24 
Investigations     
Blood creatine phosphokinase increased † 1     
# participants affected / at risk   17/531 (3.20%)   17/266 (6.39%) 
# events   20   17 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   70/531 (13.18%)   29/266 (10.90%) 
# events   86   35 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   28/531 (5.27%)   14/266 (5.26%) 
# events   30   15 
Skin and subcutaneous tissue disorders     
Pruritus † 1     
# participants affected / at risk   15/531 (2.82%)   15/266 (5.64%) 
# events   18   16 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 18.1



  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
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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: NCT02131233     History of Changes
Other Study ID Numbers: 0518-292
2013-001939-47 ( EudraCT Number )
Study First Received: May 2, 2014
Results First Received: September 7, 2016
Last Updated: May 17, 2017