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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
Enrollment 342
Recruitment Details  
Pre-assignment Details 210 participants were randomized to Part I and 132 participants were randomized to Part II.
Arm/Group Title 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
Hide Arm/Group Description Doravirine 25 mg once daily plus TRUVADA once daily in Part I Doravirine 50 mg once daily plus TRUVADA once daily in Part I Doravirine 100 mg once daily plus TRUVADA once daily in Part I Doravirine 200 mg once daily plus TRUVADA once daily in Part I Efavirenz 600 mg once daily plus TRUVADA once daily in Part I Doravirine 100 mg once daily plus TRUVADA once daily in Part II Efavirenz 600 mg once daily plus TRUVADA once daily in Part II
Period Title: Randomized Participants
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 Title: Treatment: Part I
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
Reason Not Completed
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 Title: Treatment: Part II
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
Reason Not Completed
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.
Arm/Group Title 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
Hide Arm/Group Description Doravirine 25 mg once daily plus TRUVADA once daily Doravirine 50 mg once daily plus TRUVADA once daily Doravirine 100 mg once daily plus TRUVADA once daily Doravirine 200 mg once daily plus TRUVADA once daily Efavirenz 600 mg once daily plus TRUVADA once daily Total of all reporting groups
Overall Number of Baseline Participants 40 43 108 41 108 340
Hide Baseline Analysis Population Description
All Treated participants randomized to doravirine or efavirenz using an interactive voice response system (IVRS)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 43 participants 108 participants 41 participants 108 participants 340 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 108 participants 41 participants 108 participants 340 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%
1.Primary Outcome
Title Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)
Hide Description Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-24.
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I.
Arm/Group Title Doravirine 25 mg: Part I Doravirine 50 mg: Part I Doravirine 100 mg : Part I Doravirine 200 mg: Part I Efavirenz 600 mg: Part I
Hide Arm/Group Description:
Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
Overall Number of Participants Analyzed 40 43 42 41 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
90.0
(76.3 to 97.2)
93.0
(80.9 to 98.5)
71.4
(55.4 to 84.3)
85.4
(70.8 to 94.4)
83.3
(68.6 to 93.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 25 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
-9.0 to 22.4
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doravirine 50 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
-4.6 to 24.9
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg : Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value -11.9
Confidence Interval (2-Sided) 95%
-27.9 to 6.3
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Doravirine 200 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
-14.5 to 18.4
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
2.Primary Outcome
Title Percentage of Participants Who Discontinued Study Therapy Due to AEs in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)
Hide Description Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who discontinued therapy due to an AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product.The percentage of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Weeks 0-24.
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I.
Arm/Group Title Doravirine 25 mg: Part I Doravirine 50 mg: Part I Doravirine 100 mg: Part I Doravirine 200 mg: Part I Efavirenz 600 mg: Part I
Hide Arm/Group Description:
Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
Overall Number of Participants Analyzed 40 43 42 41 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2.5
(0.1 to 13.2)
7.0
(1.5 to 19.1)
2.4
(0.1 to 12.6)
0.0
(0.0 to 8.6)
4.8
(0.6 to 16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 25 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-13.7 to 8.8
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doravirine 50 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
-9.9 to 14.7
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-13.8 to 8.2
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Doravirine 200 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value -4.8
Confidence Interval (2-Sided) 95%
-15.9 to 4.1
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
3.Primary Outcome
Title Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
Hide Description Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was assessed for Weeks 0-24.
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
75.0
(65.7 to 82.8)
85.2
(77.1 to 91.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -10.2
Confidence Interval (2-Sided) 95%
-20.9 to 0.5
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
4.Primary Outcome
Title Percentage of Participants With CNS Events by Week 8: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
Hide Description Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 8 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-8.
Time Frame Up to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
24.1
(16.4 to 33.3)
44.4
(34.9 to 54.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Superiority analysis
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value -20.4
Confidence Interval (2-Sided) 95%
-32.4 to -7.8
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
5.Primary Outcome
Title Percentage of Participants With CNS Events by Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
Hide Description Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 24 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-24.
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
26.9
(18.8 to 36.2)
47.2
(37.5 to 57.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Superiority analysis
Method Miettinen and Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference (Doravirine - Efavirenz)
Estimated Value -20.4
Confidence Interval (2-Sided) 95%
-32.6 to -7.5
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
6.Primary Outcome
Title Percentage of Participants With Virologic Response (HIV-1 RNA) < 40 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)
Hide Description Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy.This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 24 weeks of study treatment.
Arm/Group Title Doravirine 25 mg: Part I Doravirine 50 mg: Part I Doravirine 100 mg: Part I Doravirine 200 mg: Part I Efavirenz 600 mg: Part I
Hide Arm/Group Description:
Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
Overall Number of Participants Analyzed 40 43 42 41 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
80.0
(64.4 to 90.9)
74.4
(58.8 to 86.5)
71.4
(55.4 to 84.3)
80.5
(65.1 to 91.2)
64.3
(48.0 to 78.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 25 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
-4.1 to 34.4
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doravirine 50 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
-9.6 to 29.1
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 6.6
Confidence Interval (2-Sided) 95%
-13.2 to 26.0
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Doravirine 200 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 15.9
Confidence Interval (2-Sided) 95%
-3.4 to 34.4
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
7.Primary Outcome
Title 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)
Hide Description Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 24 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 107 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
72.9
(63.4 to 81.0)
73.1
(63.8 to 81.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-13.2 to 11.2
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
8.Secondary Outcome
Title 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)
Hide Description Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 48 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
77.8
(68.8 to 85.2)
79.4
(70.5 to 86.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-12.9 to 9.2
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
9.Secondary Outcome
Title 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)
Hide Description Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 96 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
75.0
(65.7 to 82.8)
75.9
(66.7 to 83.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-12.4 to 10.7
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
10.Secondary Outcome
Title Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)
Hide Description Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay.The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 24 weeks of study treatment.
Arm/Group Title Doravirine 25 mg: Part I Doravirine 50 mg: Part I Doravirine 100 mg: Part I Doravirine 200 mg: Part I Efavirenz 600 mg: Part I
Hide Arm/Group Description:
Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
Overall Number of Participants Analyzed 40 43 42 41 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
85.0
(70.2 to 94.3)
83.7
(69.3 to 93.2)
92.9
(80.5 to 98.5)
90.2
(76.9 to 97.3)
81.0
(65.9 to 91.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 25 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-12.5 to 21.5
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doravirine 50 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-13.9 to 19.8
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 12.2
Confidence Interval (2-Sided) 95%
-2.5 to 28.0
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Doravirine 200 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 9.5
Confidence Interval (2-Sided) 95%
-6.2 to 25.7
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
11.Secondary Outcome
Title 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)
Hide Description Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This secondary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 24 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 107 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
89.7
(82.3 to 94.8)
87.0
(79.2 to 92.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 2.7
Confidence Interval 95%
-6.1 to 11.7
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
12.Secondary Outcome
Title 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)
Hide Description Evaluation of the antiretroviral activity of doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA for 24 weeks, as measured by the percentage of participants with HIV-1 RNA <200 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. This primary outcome was analyzed for RNA <200 copies/mL in Part I & Part II combined.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV RNA (<200 copies/mL) at 48 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
85.2
(77.1 to 91.3)
85.0
(76.9 to 91.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-9.7 to 9.9
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
13.Secondary Outcome
Title 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)
Hide Description Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-96. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 96 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
79.6
(70.8 to 86.8)
75.9
(66.7 to 83.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % response
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
-7.3 to 15.0
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
14.Secondary Outcome
Title Change From Baseline in CD4 T Lymphocyte Cell Count at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)
Hide Description Evaluation of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, and 200 mg), compared with participants receiving efavirenz 600 mg. The Observed Failure (OF) approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment.
Arm/Group Title Doravirine 25 mg: Part I Doravirine 50 mg: Part I Doravirine 100 mg: Part I Doravirine 200 mg: Part I Efavirenz 600 mg: Part I
Hide Arm/Group Description:
Doravirine 25 mg once daily plus TRUVADA once daily received in Part I
Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I
Doravirine 200 mg once daily plus TRUVADA once daily received in Part I
Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I
Overall Number of Participants Analyzed 38 41 41 40 40
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
154.1
(115.1 to 193.1)
112.9
(74.5 to 151.2)
133.6
(100.4 to 166.8)
140.7
(95.6 to 185.7)
121.1
(73.3 to 169.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 25 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CD4 change
Estimated Value 33.0
Confidence Interval (2-Sided) 95%
-28.1 to 94.0
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Doravirine 50 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CD4 change
Estimated Value -8.3
Confidence Interval (2-Sided) 95%
-68.5 to 51.9
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CD4 change
Estimated Value 12.5
Confidence Interval (2-Sided) 95%
-44.6 to 69.5
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Doravirine 200 mg: Part I, Efavirenz 600 mg: Part I
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CD4 change
Estimated Value 19.6
Confidence Interval (2-Sided) 95%
-45.1 to 84.2
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
15.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
Hide Description Assessment of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 106 101
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
152.3
(121.7 to 182.8)
146.0
(113.1 to 178.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CD4 change
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
-38.2 to 50.8
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
16.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
Hide Description Assessment of the change from baseline in the CD4 count at Week 48 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 48 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 102 100
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
191.9
(160.8 to 223.1)
194.5
(163.2 to 225.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CD4 change
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-46.5 to 41.3
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
17.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
Hide Description A secondary endpoint in Part I/II combined was the change from baseline in the CD4 count at Week 96 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 96 weeks of study treatment.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 95 93
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
259.2
(220.0 to 298.3)
263.6
(218.1 to 309.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in CD4 change
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-64.0 to 55.1
Estimation Comments A positive value would be considered as favoring doravirine over efavirenz.
18.Secondary Outcome
Title Percentage of Participants With At Least 1 AE in Weeks 0-48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
Hide Description A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 48 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-48.
Time Frame Up to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
87.0
(79.2 to 92.7)
89.8
(82.5 to 94.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-11.7 to 6.0
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
19.Secondary Outcome
Title Percentage of Participants With At Least 1 AE in Weeks 0-96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)
Hide Description A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 96 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-96.
Time Frame Up to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.
Arm/Group Title Doravirine 100 mg: Part I/II (Combined) Efavirenz 600 mg: Part I/II (Combined)
Hide Arm/Group Description:
Doravirine 100 mg once daily plus TRUVADA once daily received in either Part I or Part II
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
89.8
(82.5 to 94.8)
96.3
(90.8 to 99.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doravirine 100 mg: Part I/II (Combined), Efavirenz 600 mg: Part I/II (Combined)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -6.5
Confidence Interval (2-Sided) 95%
-14.1 to 0.3
Estimation Comments A negative value would be considered as favoring doravirine over efavirenz.
Time Frame 96 weeks
Adverse Event Reporting Description All Treated participants randomized to doravirine or efavirenz using an IVRS
 
Arm/Group Title Doravirine 25 mg (n=40) Doravirine 50 mg (n=43) Doravirine 100 mg (n=108) Doravirine 200 mg (n=41) Efavirenz 600 mg: Part I (n=108)
Hide Arm/Group Description Doravirine 25 mg once daily plus TRUVADA once daily received in Part I Doravirine 50 mg once daily plus TRUVADA once daily received in Part I Doravirine 100 mg once daily plus TRUVADA once daily received in Part I & Part II (Combined) Doravirine 200 mg once daily plus TRUVADA once daily received in Part I Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I & Part II (Combined)
All-Cause Mortality
Doravirine 25 mg (n=40) Doravirine 50 mg (n=43) Doravirine 100 mg (n=108) Doravirine 200 mg (n=41) Efavirenz 600 mg: Part I (n=108)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Doravirine 25 mg (n=40) Doravirine 50 mg (n=43) Doravirine 100 mg (n=108) Doravirine 200 mg (n=41) Efavirenz 600 mg: Part I (n=108)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/40 (10.00%)      1/43 (2.33%)      11/108 (10.19%)      3/41 (7.32%)      13/108 (12.04%)    
Cardiac disorders           
Cardiomyopathy  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 1/41 (2.44%)  1 0/108 (0.00%)  0
Pericardial effusion  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 1/41 (2.44%)  1 0/108 (0.00%)  0
Ear and labyrinth disorders           
Deafness  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Hepatobiliary disorders           
Biliary dyskinesia  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 1/41 (2.44%)  1 0/108 (0.00%)  0
Cholecystitis  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Cholecystitis acute  1  1/40 (2.50%)  1 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 0/108 (0.00%)  0
Hepatitis toxic  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Infections and infestations           
Abdominal abscess  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Acute hepatitis C  1  1/40 (2.50%)  1 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 0/108 (0.00%)  0
Cellulitis  1  1/40 (2.50%)  1 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 0/108 (0.00%)  0
Cryptosporidiosis infection  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 1/41 (2.44%)  1 0/108 (0.00%)  0
Diverticulitis  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Gastroenteritis shigella  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Hepatitis C  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Pharyngotonsillitis  1  0/40 (0.00%)  0 1/43 (2.33%)  1 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Pneumonia  1  1/40 (2.50%)  1 0/43 (0.00%)  0 0/108 (0.00%)  0 1/41 (2.44%)  1 0/108 (0.00%)  0
Sinusitis  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Injury, poisoning and procedural complications           
Foreign body  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Jaw fracture  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Tendon rupture  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Musculoskeletal and connective tissue disorders           
Costochondritis  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
B-cell unclassifiable lymphoma high grade  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Basal cell carcinoma  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Hodgkin's disease  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Kaposi's sarcoma  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Nervous system disorders           
Dizziness  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Headache  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Hemiparesis  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Peroneal nerve palsy  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Psychiatric disorders           
Bipolar I disorder  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Depression  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Drug abuse  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Suicidal ideation  1  0/40 (0.00%)  0 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 2/108 (1.85%)  2
Respiratory, thoracic and mediastinal disorders           
Pleural effusion  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 1/41 (2.44%)  1 0/108 (0.00%)  0
Vascular disorders           
Deep vein thrombosis  1  0/40 (0.00%)  0 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 1/108 (0.93%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doravirine 25 mg (n=40) Doravirine 50 mg (n=43) Doravirine 100 mg (n=108) Doravirine 200 mg (n=41) Efavirenz 600 mg: Part I (n=108)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/40 (77.50%)      35/43 (81.40%)      78/108 (72.22%)      36/41 (87.80%)      82/108 (75.93%)    
Ear and labyrinth disorders           
Ear pain  1  3/40 (7.50%)  3 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 0/108 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  3/40 (7.50%)  3 3/43 (6.98%)  3 5/108 (4.63%)  5 0/41 (0.00%)  0 4/108 (3.70%)  4
Abdominal pain upper  1  1/40 (2.50%)  2 3/43 (6.98%)  3 4/108 (3.70%)  5 2/41 (4.88%)  2 5/108 (4.63%)  9
Constipation  1  2/40 (5.00%)  2 4/43 (9.30%)  4 2/108 (1.85%)  2 0/41 (0.00%)  0 4/108 (3.70%)  4
Diarrhea  1  10/40 (25.00%)  10 4/43 (9.30%)  4 16/108 (14.81%)  18 5/41 (12.20%)  5 18/108 (16.67%)  20
Hemorrhoids  1  1/40 (2.50%)  1 1/43 (2.33%)  1 4/108 (3.70%)  4 0/41 (0.00%)  0 6/108 (5.56%)  6
Nausea  1  3/40 (7.50%)  3 7/43 (16.28%)  8 13/108 (12.04%)  16 9/41 (21.95%)  9 11/108 (10.19%)  12
Vomiting  1  4/40 (10.00%)  4 1/43 (2.33%)  1 6/108 (5.56%)  7 1/41 (2.44%)  1 7/108 (6.48%)  8
General disorders           
Fatigue  1  7/40 (17.50%)  7 5/43 (11.63%)  7 6/108 (5.56%)  9 5/41 (12.20%)  7 7/108 (6.48%)  7
Pyrexia  1  1/40 (2.50%)  1 1/43 (2.33%)  1 6/108 (5.56%)  7 0/41 (0.00%)  0 3/108 (2.78%)  4
Infections and infestations           
Acute sinusitis  1  1/40 (2.50%)  1 3/43 (6.98%)  3 2/108 (1.85%)  2 2/41 (4.88%)  2 1/108 (0.93%)  2
Bronchitis  1  5/40 (12.50%)  7 3/43 (6.98%)  5 5/108 (4.63%)  5 5/41 (12.20%)  7 12/108 (11.11%)  13
Conjunctivitis  1  1/40 (2.50%)  1 2/43 (4.65%)  2 6/108 (5.56%)  7 0/41 (0.00%)  0 3/108 (2.78%)  3
Gastroenteritis  1  1/40 (2.50%)  2 2/43 (4.65%)  3 9/108 (8.33%)  10 2/41 (4.88%)  2 1/108 (0.93%)  1
Influenza  1  6/40 (15.00%)  9 2/43 (4.65%)  2 3/108 (2.78%)  3 5/41 (12.20%)  5 2/108 (1.85%)  2
Nasopharyngitis  1  3/40 (7.50%)  4 5/43 (11.63%)  12 19/108 (17.59%)  31 12/41 (29.27%)  17 13/108 (12.04%)  16
Oral herpes  1  0/40 (0.00%)  0 1/43 (2.33%)  1 2/108 (1.85%)  3 3/41 (7.32%)  3 3/108 (2.78%)  3
Pharyngitis  1  0/40 (0.00%)  0 5/43 (11.63%)  5 5/108 (4.63%)  7 2/41 (4.88%)  2 3/108 (2.78%)  4
Sinusitis  1  2/40 (5.00%)  2 2/43 (4.65%)  2 5/108 (4.63%)  7 3/41 (7.32%)  4 5/108 (4.63%)  7
Syphilis  1  4/40 (10.00%)  6 1/43 (2.33%)  2 6/108 (5.56%)  7 6/41 (14.63%)  7 8/108 (7.41%)  9
Tinea pedis  1  3/40 (7.50%)  3 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 0/108 (0.00%)  0
Tonsillitis  1  2/40 (5.00%)  2 1/43 (2.33%)  1 1/108 (0.93%)  1 3/41 (7.32%)  3 4/108 (3.70%)  4
Upper respiratory tract infection  1  4/40 (10.00%)  5 2/43 (4.65%)  6 10/108 (9.26%)  14 3/41 (7.32%)  3 13/108 (12.04%)  19
Injury, poisoning and procedural complications           
Accidental overdose  1  4/40 (10.00%)  4 1/43 (2.33%)  3 4/108 (3.70%)  5 3/41 (7.32%)  10 5/108 (4.63%)  6
Musculoskeletal and connective tissue disorders           
Arthralgia  1  2/40 (5.00%)  2 2/43 (4.65%)  2 6/108 (5.56%)  6 3/41 (7.32%)  3 3/108 (2.78%)  3
Back pain  1  2/40 (5.00%)  2 5/43 (11.63%)  7 6/108 (5.56%)  7 2/41 (4.88%)  2 10/108 (9.26%)  14
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Anogenital warts  1  0/40 (0.00%)  0 1/43 (2.33%)  1 4/108 (3.70%)  5 2/41 (4.88%)  2 6/108 (5.56%)  6
Nervous system disorders           
Dizziness  1  5/40 (12.50%)  5 5/43 (11.63%)  6 16/108 (14.81%)  17 3/41 (7.32%)  3 32/108 (29.63%)  38
Headache  1  5/40 (12.50%)  6 6/43 (13.95%)  8 14/108 (12.96%)  27 7/41 (17.07%)  7 15/108 (13.89%)  26
Somnolence  1  3/40 (7.50%)  3 0/43 (0.00%)  0 1/108 (0.93%)  1 0/41 (0.00%)  0 1/108 (0.93%)  1
Psychiatric disorders           
Abnormal dreams  1  5/40 (12.50%)  6 9/43 (20.93%)  9 7/108 (6.48%)  9 4/41 (9.76%)  4 19/108 (17.59%)  21
Anxiety  1  1/40 (2.50%)  1 2/43 (4.65%)  2 3/108 (2.78%)  4 0/41 (0.00%)  0 6/108 (5.56%)  9
Depression  1  1/40 (2.50%)  1 3/43 (6.98%)  4 4/108 (3.70%)  4 0/41 (0.00%)  0 11/108 (10.19%)  12
Insomnia  1  1/40 (2.50%)  1 6/43 (13.95%)  6 10/108 (9.26%)  10 3/41 (7.32%)  4 6/108 (5.56%)  7
Nightmare  1  1/40 (2.50%)  1 1/43 (2.33%)  1 9/108 (8.33%)  10 0/41 (0.00%)  0 10/108 (9.26%)  12
Sleep disorder  1  1/40 (2.50%)  1 2/43 (4.65%)  2 6/108 (5.56%)  6 0/41 (0.00%)  0 8/108 (7.41%)  11
Respiratory, thoracic and mediastinal disorders           
Asthma  1  2/40 (5.00%)  5 0/43 (0.00%)  0 0/108 (0.00%)  0 3/41 (7.32%)  3 2/108 (1.85%)  2
Cough  1  3/40 (7.50%)  7 1/43 (2.33%)  1 3/108 (2.78%)  4 3/41 (7.32%)  3 6/108 (5.56%)  10
Dyspnea  1  3/40 (7.50%)  3 0/43 (0.00%)  0 0/108 (0.00%)  0 0/41 (0.00%)  0 0/108 (0.00%)  0
Nasal congestion  1  1/40 (2.50%)  1 3/43 (6.98%)  3 3/108 (2.78%)  3 0/41 (0.00%)  0 3/108 (2.78%)  3
Skin and subcutaneous tissue disorders           
Acne  1  2/40 (5.00%)  2 3/43 (6.98%)  3 2/108 (1.85%)  2 0/41 (0.00%)  0 0/108 (0.00%)  0
Night sweats  1  1/40 (2.50%)  1 0/43 (0.00%)  0 1/108 (0.93%)  2 0/41 (0.00%)  0 6/108 (5.56%)  6
Pruritus  1  0/40 (0.00%)  0 3/43 (6.98%)  3 4/108 (3.70%)  4 0/41 (0.00%)  0 3/108 (2.78%)  3
Rash  1  1/40 (2.50%)  1 3/43 (6.98%)  6 6/108 (5.56%)  6 2/41 (4.88%)  2 9/108 (8.33%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
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