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A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)

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ClinicalTrials.gov Identifier: NCT01632345
Recruitment Status : Completed
First Posted : July 2, 2012
Results First Posted : December 13, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Doravirine
Drug: Efavirenz
Drug: TRUVADA®
Drug: Placebo for Doravirine
Drug: Placebo for Efavirenz

  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
210 participants were randomized to Part I and 132 participants were randomized to Part II.

Reporting Groups
  Description
Part I: Doravirine 25 mg Doravirine 25 mg once daily plus TRUVADA once daily in Part I
Part I: Doravirine 50 mg Doravirine 50 mg once daily plus TRUVADA once daily in Part I
Part I: Doravirine 100 mg Doravirine 100 mg once daily plus TRUVADA once daily in Part I
Part I: Doravirine 200 mg Doravirine 200 mg once daily plus TRUVADA once daily in Part I
Part I: Efavirenz 600 mg Efavirenz 600 mg once daily plus TRUVADA once daily in Part I
Part II: Doravirine 100 mg Doravirine 100 mg once daily plus TRUVADA once daily in Part II
Part II: Efavirenz 600 mg Efavirenz 600 mg once daily plus TRUVADA once daily in Part II

Participant Flow for 3 periods

Period 1:   Randomized Participants
    Part I: Doravirine 25 mg   Part I: Doravirine 50 mg   Part I: Doravirine 100 mg   Part I: Doravirine 200 mg   Part I: Efavirenz 600 mg   Part II: Doravirine 100 mg   Part II: Efavirenz 600 mg
STARTED   41   43   42   41   43   66   66 
COMPLETED   41   43   42   41   43   66   66 
NOT COMPLETED   0   0   0   0   0   0   0 

Period 2:   Treatment: Part I
    Part I: Doravirine 25 mg   Part I: Doravirine 50 mg   Part I: Doravirine 100 mg   Part I: Doravirine 200 mg   Part I: Efavirenz 600 mg   Part II: Doravirine 100 mg   Part II: Efavirenz 600 mg
STARTED   41   43   42   41   43   0 [1]   0 [1] 
Treated   40   43   42   41   43   0   0 
COMPLETED   29   28   32   33   30   0   0 
NOT COMPLETED   12   15   10   8   13   0   0 
Adverse Event                1                4                2                1                3                0                0 
Lack of Efficacy                0                1                0                1                1                0                0 
Lost to Follow-up                3                2                1                3                4                0                0 
Non-Compliance with Study Drug                3                2                2                1                0                0                0 
Physician Decision                2                1                0                0                1                0                0 
Pregnancy                0                1                0                0                0                0                0 
Protocol Deviation                0                0                1                1                0                0                0 
Withdrawal by Subject                3                4                4                1                4                0                0 
[1] Participants in Part II did not participate in Part I.

Period 3:   Treatment: Part II
    Part I: Doravirine 25 mg   Part I: Doravirine 50 mg   Part I: Doravirine 100 mg   Part I: Doravirine 200 mg   Part I: Efavirenz 600 mg   Part II: Doravirine 100 mg   Part II: Efavirenz 600 mg
STARTED   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   66 [2]   66 [3] 
Treated   0   0   0   0   0   66   66 
COMPLETED   0   0   0   0   0   55   55 
NOT COMPLETED   0   0   0   0   0   11   11 
Adverse Event                0                0                0                0                0                3                8 
Lost to Follow-up                0                0                0                0                0                3                1 
Non-Compliance with Study Drug                0                0                0                0                0                3                0 
Withdrawal by Subject                0                0                0                0                0                2                2 
[1] Participants in Part I did not continue in Part II.
[2] 66 new participants enrolled at 100 mg dose in Part II.
[3] 66 new participants enrolled at efavirenz treatment in Part II.



  Baseline Characteristics

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 randomized to doravirine or efavirenz using an interactive voice response system (IVRS)

Reporting Groups
  Description
Doravirine 25 mg: Part I/II Combined Doravirine 25 mg once daily plus TRUVADA once daily
Doravirine 50 mg Part I/II Combined Doravirine 50 mg once daily plus TRUVADA once daily
Doravirine 100 mg: Part I/II Combined Doravirine 100 mg once daily plus TRUVADA once daily
Doravirine 200 mg: Part I/II Combined Doravirine 200 mg once daily plus TRUVADA once daily
Efavirenz 600 mg: Part I/II Combined Efavirenz 600 mg once daily plus TRUVADA once daily
Total Total of all reporting groups

Baseline Measures
   Doravirine 25 mg: Part I/II Combined   Doravirine 50 mg Part I/II Combined   Doravirine 100 mg: Part I/II Combined   Doravirine 200 mg: Part I/II Combined   Efavirenz 600 mg: Part I/II Combined   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   43   108   41   108   340 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.9  (13.42)   38.3  (10.71)   36.8  (11.31)   34.4  (8.85)   35.2  (9.08)   36.4  (10.62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      2   5.0%      6  14.0%      9   8.3%      1   2.4%      7   6.5%      25   7.4% 
Male      38  95.0%      37  86.0%      99  91.7%      40  97.6%      101  93.5%      315  92.6% 


  Outcome Measures

1.  Primary:   Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)   [ Time Frame: Up to Week 24 ]

2.  Primary:   Percentage of Participants Who Discontinued Study Therapy Due to AEs in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)   [ Time Frame: Up to Week 24 ]

3.  Primary:   Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Up to Week 24 ]

4.  Primary:   Percentage of Participants With CNS Events by Week 8: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Up to Week 8 ]

5.  Primary:   Percentage of Participants With CNS Events by Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Up to Week 24 ]

6.  Primary:   Percentage of Participants With Virologic Response (HIV-1 RNA) < 40 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)   [ Time Frame: Week 24 ]

7.  Primary:   Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Week 24 ]

8.  Secondary:   Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Week 48 ]

9.  Secondary:   Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Week 96 ]

10.  Secondary:   Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)   [ Time Frame: Week 24 ]

11.  Secondary:   Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Week 24 ]

12.  Secondary:   Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Week 48 ]

13.  Secondary:   Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Week 96 ]

14.  Secondary:   Change From Baseline in CD4 T Lymphocyte Cell Count at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)   [ Time Frame: Baseline, Week 24 ]

15.  Secondary:   Change From Baseline in CD4 Cell Count at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Baseline, Week 24 ]

16.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Baseline, Week 48 ]

17.  Secondary:   Change From Baseline in CD4 Cell Count at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Baseline, Week 96 ]

18.  Secondary:   Percentage of Participants With At Least 1 AE in Weeks 0-48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Up to Week 48 ]

19.  Secondary:   Percentage of Participants With At Least 1 AE in Weeks 0-96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)   [ Time Frame: Up to Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: NCT01632345     History of Changes
Other Study ID Numbers: 1439-007
MK-1439-007 ( Other Identifier: Merck )
2012-001573-93 ( EudraCT Number )
First Submitted: June 28, 2012
First Posted: July 2, 2012
Results First Submitted: November 16, 2017
Results First Posted: December 13, 2017
Last Update Posted: August 29, 2018