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Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)

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.
 
ClinicalTrials.gov Identifier: NCT02715700
Recruitment Status : Completed
First Posted : March 22, 2016
Results First Posted : June 3, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus (HIV) Infection
Interventions Drug: Methadone
Drug: Doravirine
Enrollment 14
Recruitment Details Adult male and female participants on stable methadone maintenance therapy were recruited at 2 study sites in the United States.
Pre-assignment Details  
Arm/Group Title Maintenance Methadone + Doravirine
Hide Arm/Group Description Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Days 1 to 7 and doravirine 100 mg on Days 2 to 6.
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title Maintenance Methadone + Doravirine
Hide Arm/Group Description Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Days 1 to 7 and doravirine 100 mg on Days 2 to 6.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
36.7  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
7
  50.0%
Male
7
  50.0%
1.Primary Outcome
Title Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of R-Methadone
Hide Description The AUC0-24 of the R- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by liquid chromatographic-tandem mass spectrometric (LC-MS/MS) detection. The lower limit of quantification (LLoQ) was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng*hr/mL/mg
55.8
(46.4 to 67.1)
53.2
(44.6 to 63.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.95
Confidence Interval (2-Sided) 90%
0.90 to 1.01
Estimation Comments [Not Specified]
2.Primary Outcome
Title Plasma Concentration at 24 Hours After Dosing (C24) of R-Methadone
Hide Description The C24 of the R- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL/mg
1.91
(1.56 to 2.34)
1.82
(1.45 to 2.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments GMR of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.95
Confidence Interval (2-Sided) 90%
0.88 to 1.03
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of R-Methadone
Hide Description The Cmax of the R- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL/mg
3.41
(2.89 to 4.01)
3.33
(2.83 to 3.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments GMR of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.93 to 1.03
Estimation Comments [Not Specified]
4.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of R-Methadone
Hide Description The Tmax of the R- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Median (Full Range)
Unit of Measure: Hours
2.00
(1.00 to 6.00)
2.01
(1.02 to 4.00)
5.Primary Outcome
Title AUC0-24 of S-Methadone
Hide Description The AUC0-24 of the S- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng*hr/mL/mg
52.0
(38.3 to 70.4)
50.8
(37.5 to 68.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.90 to 1.06
Estimation Comments [Not Specified]
6.Primary Outcome
Title C24 of S-Methadone
Hide Description The C24 of the S- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL/mg
1.51
(1.03 to 2.22)
1.47
(0.974 to 2.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments GMR of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
0.86 to 1.10
Estimation Comments [Not Specified]
7.Primary Outcome
Title Cmax of S-Methadone
Hide Description The Cmax of the S- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL/mg
3.77
(2.95 to 4.82)
3.67
(2.87 to 4.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments GMR of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
0.91 to 1.04
Estimation Comments [Not Specified]
8.Primary Outcome
Title Tmax of S-Methadone
Hide Description The Tmax of the S- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Median (Full Range)
Unit of Measure: Hours
1.99
(1.00 to 3.00)
2.00
(1.02 to 4.00)
9.Primary Outcome
Title AUC0-24 of Total Methadone
Hide Description The AUC0-24 of total methadone was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng*hr/mL/mg
109
(86.0 to 137)
105
(82.9 to 132)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.90 to 1.03
Estimation Comments [Not Specified]
10.Primary Outcome
Title C24 of Total Methadone
Hide Description The C24 of total methadone was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL/mg
3.48
(2.65 to 4.57)
3.34
(2.48 to 4.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments GMR of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.87 to 1.05
Estimation Comments [Not Specified]
11.Primary Outcome
Title Cmax of Total Methadone
Hide Description The Cmax of total methadone was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL/mg
7.19
(5.86 to 8.82)
7.01
(5.72 to 8.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Methadone, Maintenance Methadone + Doravirine
Comments [Not Specified]
Type of Statistical Test Other
Comments GMR of Methadone + Doravirine/Methadone Alone
Method of Estimation Estimation Parameter GMR
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.92 to 1.03
Estimation Comments [Not Specified]
12.Primary Outcome
Title Tmax of Total Methadone
Hide Description The Tmax of total methadone was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.
Time Frame Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included.
Arm/Group Title Maintenance Methadone Maintenance Methadone + Doravirine
Hide Arm/Group Description:
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose on Day 1.
Participants maintained on a stable methadone regimen (20 to 200 mg once daily) for ≥14 days prior to Day 1 received the methadone maintenance dose + doravirine 100 mg once daily on Days 2 to 6.
Overall Number of Participants Analyzed 14 14
Median (Full Range)
Unit of Measure: Hours
2.00
(1.00 to 6.00)
2.01
(1.02 to 4.00)
Time Frame Up to 21 days
Adverse Event Reporting Description All treated participants are included.
 
Arm/Group Title Maintenance Methadone (Day 1) Maintenance Methadone + Doravirine (Days 2 to 6) Maintenance Methadone (Day 7) Safety Follow-Up (Days 8 to 21)
Hide Arm/Group Description Participants received the methadone maintenance dose on Day 1. Participants received the methadone maintenance dose and doravirine 100 mg on Days 2 to 6. Participants received the maintenance methadone dose on Day 7. Participants were monitored for safety for 14 days after the final dose of study treatment.
All-Cause Mortality
Maintenance Methadone (Day 1) Maintenance Methadone + Doravirine (Days 2 to 6) Maintenance Methadone (Day 7) Safety Follow-Up (Days 8 to 21)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
Maintenance Methadone (Day 1) Maintenance Methadone + Doravirine (Days 2 to 6) Maintenance Methadone (Day 7) Safety Follow-Up (Days 8 to 21)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maintenance Methadone (Day 1) Maintenance Methadone + Doravirine (Days 2 to 6) Maintenance Methadone (Day 7) Safety Follow-Up (Days 8 to 21)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      7/14 (50.00%)      2/14 (14.29%)      1/14 (7.14%)    
Gastrointestinal disorders         
Abdominal discomfort  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0
General disorders         
Drug withdrawal syndrome  1  0/14 (0.00%)  0 2/14 (14.29%)  2 1/14 (7.14%)  1 0/14 (0.00%)  0
Investigations         
Blood urine present  1  0/14 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
Nervous system disorders         
Dizziness  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0
Headache  1  0/14 (0.00%)  0 2/14 (14.29%)  2 0/14 (0.00%)  0 0/14 (0.00%)  0
Psychiatric disorders         
Euphoric mood  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Sinus congestion  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0
1
Term from vocabulary, MedDRA v. 19.0
Indicates events were collected by systematic assessment
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02715700    
Other Study ID Numbers: 1439-045
MK-1439-045 ( Other Identifier: Merck Protocol Number )
First Submitted: March 17, 2016
First Posted: March 22, 2016
Results First Submitted: September 24, 2018
Results First Posted: June 3, 2019
Last Update Posted: June 25, 2019