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Safety and Efficacy of MK-1439A in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030) (DRIVE BEYOND)

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ClinicalTrials.gov Identifier: NCT02629822
Recruitment Status : Active, not recruiting
First Posted : December 14, 2015
Results First Posted : December 26, 2019
Last Update Posted : February 5, 2020
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 HIV-1 Infection
Intervention Drug: MK-1439A
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Period Title: Base Study
Started 10
Completed 7
Not Completed 3
Reason Not Completed
Lost to Follow-up             2
Non-Compliance With Study Drug             1
Period Title: Extension Study
Started 6 [1]
Completed 0
Not Completed 6
Reason Not Completed
Extension Period is Ongoing             6
[1]
Enrollment in Extension Study was voluntary.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
37.1  (32.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
2
  20.0%
Not Hispanic or Latino
6
  60.0%
Unknown or Not Reported
2
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
1
  10.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  30.0%
White
5
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  10.0%
1.Primary Outcome
Title Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48
Hide Description The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
100.0
(63.1 to 100.0)
2.Primary Outcome
Title Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48
Hide Description The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
90.0
3.Primary Outcome
Title Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.
Hide Description The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0
4.Primary Outcome
Title Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96
Hide Description The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
90.0
5.Primary Outcome
Title Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96
Hide Description The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0
6.Secondary Outcome
Title Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96
Hide Description The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
100.0
(59.0 to 100.0)
7.Secondary Outcome
Title Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48
Hide Description The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
100.0
(63.1 to 100.0)
8.Secondary Outcome
Title Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96
Hide Description The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
100.0
(59.0 to 100.0)
9.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description The change from baseline in CD4 cell count at Week 48 was calculated.
Time Frame Baseline (Day 1) and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 8
Mean (95% Confidence Interval)
Unit of Measure: Cells/mm^3
Baseline for the Week 48 Population
409
(293.5 to 525.0)
Change from Baseline at Week 48
132
(24.4 to 239.8)
10.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 96
Hide Description The change from baseline in CD4 cell count at Week 96 was calculated.
Time Frame Baseline (Day 1) and Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 7
Mean (95% Confidence Interval)
Unit of Measure: Cells/mm^3
Baseline for the Week 96 Population
437
(323.9 to 550.7)
Change from Baseline at Week 96
153
(23.0 to 282.8)
11.Secondary Outcome
Title Time to Loss of Virologic Response
Hide Description The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who experienced protocol-defined virologic failure, received ≥1 dose of MK-1439A, had baseline and later data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations. Participants who did not experience virologic failure were excluded from the analysis population.
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description:
Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
Overall Number of Participants Analyzed 1
Mean (Full Range)
Unit of Measure: Days
166
(166 to 166)
Time Frame Up to 96 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DOR/3TC/TDF
Hide Arm/Group Description Treatment-naïve HIV-1 infected participants with non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance were treated with open-label MK-1439A consisting of a single fixed-dose combination (FDC) tablet of 100 mg of MK-1439 (doravirine, DOR), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF), administered orally once daily for 96 weeks. For some participants who continued into the study extension, study treatment may have continued for approximately an additional 96 weeks, through a total of approximately 192 weeks of treatment.
All-Cause Mortality
DOR/3TC/TDF
Affected / at Risk (%)
Total   0/10 (0.00%)    
Hide Serious Adverse Events
DOR/3TC/TDF
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Immune system disorders   
Allergy to arthropod sting  1  1/10 (10.00%)  1
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DOR/3TC/TDF
Affected / at Risk (%) # Events
Total   9/10 (90.00%)    
Cardiac disorders   
Palpitations  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Abdominal discomfort  1  2/10 (20.00%)  3
Abdominal pain  1  1/10 (10.00%)  1
Anogenital dysplasia  1  1/10 (10.00%)  1
Constipation  1  1/10 (10.00%)  1
Defaecation urgency  1  1/10 (10.00%)  1
Diarrhoea  1  2/10 (20.00%)  2
Dry mouth  1  1/10 (10.00%)  1
Gastrointestinal tract irritation  1  1/10 (10.00%)  1
Nausea  1  2/10 (20.00%)  4
Vomiting  1  1/10 (10.00%)  3
General disorders   
Fatigue  1  2/10 (20.00%)  2
Pyrexia  1  1/10 (10.00%)  1
Infections and infestations   
Folliculitis  1  1/10 (10.00%)  1
Hepatitis syphilitic  1  1/10 (10.00%)  1
Herpes simplex  1  1/10 (10.00%)  1
Infected cyst  1  1/10 (10.00%)  1
Influenza  1  1/10 (10.00%)  1
Lower respiratory tract infection  1  1/10 (10.00%)  1
Nasopharyngitis  1  3/10 (30.00%)  5
Oropharyngeal gonococcal infection  1  1/10 (10.00%)  1
Otitis externa  1  1/10 (10.00%)  1
Proctitis gonococcal  1  1/10 (10.00%)  1
Secondary syphilis  1  1/10 (10.00%)  1
Shigella infection  1  1/10 (10.00%)  1
Injury, poisoning and procedural complications   
Arthropod bite  1  1/10 (10.00%)  1
Exposure to communicable disease  1  1/10 (10.00%)  2
Eye contusion  1  1/10 (10.00%)  1
Fall  1  1/10 (10.00%)  1
Hand fracture  1  1/10 (10.00%)  1
Metabolism and nutrition disorders   
Hyperlipidaemia  1  1/10 (10.00%)  1
Vitamin D deficiency  1  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/10 (20.00%)  2
Back pain  1  4/10 (40.00%)  4
Neck pain  1  2/10 (20.00%)  2
Nervous system disorders   
Dizziness  1  1/10 (10.00%)  1
Dysaesthesia  1  1/10 (10.00%)  1
Dysgeusia  1  1/10 (10.00%)  1
Dystonia  1  1/10 (10.00%)  1
Sciatica  1  2/10 (20.00%)  2
Psychiatric disorders   
Abnormal dreams  1  1/10 (10.00%)  1
Insomnia  1  1/10 (10.00%)  1
Reproductive system and breast disorders   
Penile discharge  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/10 (10.00%)  2
Oropharyngeal pain  1  1/10 (10.00%)  1
Rhinorrhoea  1  1/10 (10.00%)  1
Sinus congestion  1  1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Photosensitivity reaction  1  1/10 (10.00%)  1
Rash  1  1/10 (10.00%)  1
1
Term from vocabulary, MedDRA 21.1
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.
Subsequent to the multicenter publication (or after public disclosure of the results at www.clinicaltrials.gov if multicenter manuscript is not planned), an investigator and colleagues may publish their data independently. Sponsor must have opportunity to review proposed abstracts, manuscripts or presentations 45 days prior to submission for publication/presentation. Confidential information must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
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: NCT02629822    
Other Study ID Numbers: 1439A-030
2015-003616-20 ( EudraCT Number )
MK-1439A-030 ( Other Identifier: Merck Protocol Number )
First Submitted: December 10, 2015
First Posted: December 14, 2015
Results First Submitted: November 14, 2019
Results First Posted: December 26, 2019
Last Update Posted: February 5, 2020