Trial Outcomes & Findings for Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030) (NCT NCT02629822)
NCT ID: NCT02629822
Last Updated: 2021-10-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Week 48
Results posted on
2021-10-26
Participant Flow
Participants were enrolled at 7 study sites in Canada, France, Spain, UK, and USA.
Participant milestones
| Measure |
DOR/3TC/TDF
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Base Study
STARTED
|
10
|
|
Base Study
COMPLETED
|
7
|
|
Base Study
NOT COMPLETED
|
3
|
|
Extension Study
STARTED
|
6
|
|
Extension Study
COMPLETED
|
4
|
|
Extension Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
DOR/3TC/TDF
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
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|---|---|
|
Base Study
Lost to Follow-up
|
2
|
|
Base Study
Non-Compliance With Study Drug
|
1
|
|
Extension Study
Adverse Event
|
1
|
|
Extension Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)
Baseline characteristics by cohort
| Measure |
DOR/3TC/TDF
n=10 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
37.1 Years
STANDARD_DEVIATION 32.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: 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 transmitted resistance-associated mutations.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=8 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48
|
100.0 Percentage of Participants
Interval 63.1 to 100.0
|
PRIMARY outcome
Timeframe: Up to Week 48Population: All participants who received ≥1 dose of MK-1439A.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=10 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
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|---|---|
|
Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48
|
90.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: All participants who received ≥1 dose of MK-1439A.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=10 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: All participants who received ≥1 dose of MK-1439A.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=10 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
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|---|---|
|
Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96
|
90.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: All participants who received ≥1 dose of MK-1439A.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=10 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 96Population: 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 transmitted resistance-associated mutations.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=7 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96
|
100.0 Percentage of Participants
Interval 59.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 48Population: 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 transmitted resistance-associated mutations.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=8 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48
|
100.0 Percentage of Participants
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: Week 96Population: 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 transmitted resistance-associated mutations.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=7 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96
|
100.0 Percentage of Participants
Interval 59.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: 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 transmitted resistance-associated mutations.
The change from baseline in CD4 cell count at Week 48 was calculated.
Outcome measures
| Measure |
DOR/3TC/TDF
n=8 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Change From Baseline in CD4 Cell Count at Week 48
Baseline for the Week 48 Population
|
409 Cells/mm^3
Interval 293.5 to 525.0
|
|
Change From Baseline in CD4 Cell Count at Week 48
Change from Baseline at Week 48
|
132 Cells/mm^3
Interval 24.4 to 239.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 96Population: 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 transmitted resistance-associated mutations.
The change from baseline in CD4 cell count at Week 96 was calculated.
Outcome measures
| Measure |
DOR/3TC/TDF
n=7 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Change From Baseline in CD4 Cell Count at Week 96
Baseline for the Week 96 Population
|
437 Cells/mm^3
Interval 323.9 to 550.7
|
|
Change From Baseline in CD4 Cell Count at Week 96
Change from Baseline at Week 96
|
153 Cells/mm^3
Interval 23.0 to 282.8
|
SECONDARY outcome
Timeframe: Up to Week 96Population: 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 transmitted resistance-associated mutations. Participants who did not experience virologic failure were excluded from the analysis population.
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.
Outcome measures
| Measure |
DOR/3TC/TDF
n=1 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
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|---|---|
|
Time to Loss of Virologic Response
|
166 Days
Interval 166.0 to 166.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 192Population: All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations.
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) \<50 copies/mL in plasma at Week 192 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 192 visit.
Outcome measures
| Measure |
DOR/3TC/TDF
n=4 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 192Population: All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations.
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) \<40 copies/mL in plasma at Week 192 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 192 visit. Participants with reading below the LoQ were considered to have \<40 copies/mL.
Outcome measures
| Measure |
DOR/3TC/TDF
n=4 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192
|
100.0 Percentage of Participants
Interval 39.8 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) and Week 192Population: All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations.
The change from baseline in CD4 cell count at Week 192 was calculated.
Outcome measures
| Measure |
DOR/3TC/TDF
n=4 Participants
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study.
|
|---|---|
|
Change From Baseline in CD4 Cell Count at Week 192
Baseline for the Week 192 Population
|
479 Cells/mm^3
Interval 310.0 to 648.5
|
|
Change From Baseline in CD4 Cell Count at Week 192
Change from Baseline at Week 192
|
196 Cells/mm^3
Interval 27.4 to 364.1
|
Adverse Events
DOR/3TC/TDF Base Study: Day 1 to Week 96
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
DOR/3TC/TDF Study Extension: Week 97 to Week 192
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DOR/3TC/TDF Base Study: Day 1 to Week 96
n=10 participants at risk
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study.
|
DOR/3TC/TDF Study Extension: Week 97 to Week 192
n=6 participants at risk
Eligible participants who chose to continue on study received the same MK-1439A regimen from Week 96 to Week 192 during the Extension Study.
|
|---|---|---|
|
Immune system disorders
Allergy to arthropod sting
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
Other adverse events
| Measure |
DOR/3TC/TDF Base Study: Day 1 to Week 96
n=10 participants at risk
Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study.
|
DOR/3TC/TDF Study Extension: Week 97 to Week 192
n=6 participants at risk
Eligible participants who chose to continue on study received the same MK-1439A regimen from Week 96 to Week 192 during the Extension Study.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.0%
2/10 • Number of events 4 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Defaecation urgency
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
2/10 • Number of events 2 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Gastrointestinal tract irritation
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 4 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 3 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/10 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Folliculitis
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/10 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Hepatitis syphilitic
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Herpes simplex
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Infected cyst
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Lower respiratory tract infection
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10 • Number of events 5 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Otitis externa
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Proctitis gonococcal
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Secondary syphilis
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Shigella infection
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
10.0%
1/10 • Number of events 2 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
4/10 • Number of events 4 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
2/10 • Number of events 2 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Nervous system disorders
Dysaesthesia
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Nervous system disorders
Dystonia
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Nervous system disorders
Sciatica
|
20.0%
2/10 • Number of events 2 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Nervous system disorders
Taste disorder
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Psychiatric disorders
Abnormal dreams
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/10 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Reproductive system and breast disorders
Penile discharge
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 2 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
0.00%
0/6 • Up to 192 Weeks
All participants who received ≥1 dose of study intervention are included in AE results. All-cause mortality is based on all randomized participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER