Trial Outcomes & Findings for Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028) (NCT NCT04295772)
NCT ID: NCT04295772
Last Updated: 2024-01-31
Results Overview
The AUC0-24 of ISL in plasma was determined at steady state.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Results posted on
2024-01-31
Participant Flow
Pediatric participants who were ≥35 kg body weight and \<18 years of age were recruited at 18 study sites located in Italy, Russian Federation, Thailand, South Africa, and the United States.
Participant milestones
| Measure |
DOR/ISL: Virologically Suppressed Cohort
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
3
|
|
Overall Study
COMPLETED
|
22
|
2
|
|
Overall Study
NOT COMPLETED
|
17
|
1
|
Reasons for withdrawal
| Measure |
DOR/ISL: Virologically Suppressed Cohort
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Ongoing for safety monitoring
|
14
|
1
|
|
Overall Study
Excluded from results due to informed consent issue
|
2
|
0
|
Baseline Characteristics
Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)
Baseline characteristics by cohort
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 Participants
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.7 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
15.7 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
The AUC0-24 of ISL in plasma was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=15 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL)
|
0.114 hr*µmol/L
Geometric Coefficient of Variation 28.6
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
The Cmax of ISL in plasma was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=15 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of ISL
|
0.0245 µmol/L
Geometric Coefficient of Variation 53.4
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
The Tmax of ISL in plasma was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=15 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of ISL
|
1.00 hours
Interval 0.5 to 4.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
The t½ of ISL in plasma was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=15 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Apparent Plasma Terminal Half-life (t½) of ISL
|
16.5 hours
Geometric Coefficient of Variation 70.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
The CL/F of ISL from plasma was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=15 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Apparent Total Clearance From Plasma (CL/F) of ISL
|
22.5 L/hr
Geometric Coefficient of Variation 28.6
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
The Vz/F of ISL was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=15 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL
|
536 Liters
Geometric Coefficient of Variation 61.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 4 and 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters.
The AUC0-24 of ISL-TP in PBMCs was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=12 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs)
|
52.3 hr*pmol/10^6 cells
Geometric Coefficient of Variation 74.9
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, and 4, and 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters.
The Cmax of ISL-TP in PBMCs was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=12 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Cmax of ISL-TP in PBMCs
|
2.87 pmol/10^6 cells
Geometric Coefficient of Variation 91.6
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dose on Day 28Population: A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters.
The C24 of ISL-TP in PBMCs was determined at steady state.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=12 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
C24 of ISL-TP in PBMCs
|
2.05 pmol/10^6 cells
Geometric Coefficient of Variation 71.7
|
—
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: All participants who received ≥1 dose of study intervention are included.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 Participants
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Number of Participants Experiencing ≥1 Adverse Event (AE)
|
21 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: All participants who received ≥1 dose of study intervention are included.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 Participants
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Number of Participants Discontinuing From Study Treatment Due to an AE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants who were VS at baseline (on stable combination antiretroviral therapy \[ART\] for ≥3 months) and had data available are included.
The percentage of VS participants with HIV-1 RNA ≥50 copies/mL was determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=34 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Percentage of Virologically Suppressed (VS) Participants With HIV-1 Ribonucleic Acid (RNA) ≥50 Copies/mL
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Participants who were VS at baseline (on stable combination ART for ≥3 months) and had data available are included.
The percentage of VS participants with HIV-1 RNA \<50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=34 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Percentage of VS Participants With HIV-1 RNA <50 Copies/mL
|
94.1 percentage of participants
Interval 80.3 to 99.3
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Participants who were TN at baseline and had data available are included.
The percentage of TN participants with HIV-1 RNA \<50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=1 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Percentage of Treatment Naive (TN) Participants With HIV-1 RNA <50 Copies/mL
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: All VS participants who received ≥1 dose of study intervention and had data available are included.
CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=33 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-cells in VS Participants
|
-112.1 cells/mm^3
Interval -175.8 to -48.4
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: TN participants who received ≥1 dose of study intervention and had baseline and Week 24 data available are included.
CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=1 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Change From Baseline in CD4+ T-cells in TN Participants
|
705.0 cells/mm^3
95% CI not calculated due to n=1.
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Participants who received ≥1 dose of study intervention are included.
The number of participants with viral drug resistance to DOR was determined.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 Participants
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Incidence of Viral Drug Resistance to DOR
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Participants who received ≥1 dose of study intervention are included.
The number of participants with viral drug resistance to ISL was determined.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 Participants
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Incidence of Viral Drug Resistance to ISL
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 4, and Week 24Population: All VS and TN participants who received ≥1 dose of study intervention and have data available are included.
The palatability of the DOR/ISL tablet (whole or split) was assessed with a modified 5-point facial hedonic scale. Responses ranged from 1 ("very bad") to 5 ("very good"). Data show the number of VS and TN participants responding at each score at the designated time points.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 Participants
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Palatability of DOR/ISL Tablet
Very Bad - Day 1
|
0 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Very Bad - Week 4
|
0 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Very Bad - Week 24
|
2 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Bad - Day 1
|
0 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Bad - Week 4
|
0 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Bad - Week 24
|
3 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Neither good or bad - Day 1
|
12 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Neither good or bad - Week 4
|
11 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Neither good or bad - Week 24
|
8 Participants
|
0 Participants
|
|
Palatability of DOR/ISL Tablet
Good - Day 1
|
9 Participants
|
2 Participants
|
|
Palatability of DOR/ISL Tablet
Good - Week 4
|
11 Participants
|
2 Participants
|
|
Palatability of DOR/ISL Tablet
Good - Week 24
|
5 Participants
|
1 Participants
|
|
Palatability of DOR/ISL Tablet
Very Good - Day 1
|
16 Participants
|
1 Participants
|
|
Palatability of DOR/ISL Tablet
Very Good - Week 4
|
15 Participants
|
1 Participants
|
|
Palatability of DOR/ISL Tablet
Very Good - Week 24
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 4, and Week 24Population: All VS and TN participants who received ≥1 dose of study intervention and have data available are included.
The acceptability of the DOR/ISL tablet (whole or split) was assessed. Acceptability was assessed by monitoring for refusing the tablet, throwing up or spitting out the tablet, and gagging on the tablet. Data show the number of VS and TN participants responding at each score at the designated time points.
Outcome measures
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 Participants
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 Participants
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
|---|---|---|
|
Acceptability of DOR/ISL Tablet
Refusing - Day 1
|
0 Participants
|
0 Participants
|
|
Acceptability of DOR/ISL Tablet
Refusing - Week 4
|
0 Participants
|
0 Participants
|
|
Acceptability of DOR/ISL Tablet
Refusing - Week 24
|
0 Participants
|
0 Participants
|
|
Acceptability of DOR/ISL Tablet
Throwing Up/Spitting Out - Day 1
|
0 Participants
|
0 Participants
|
|
Acceptability of DOR/ISL Tablet
Throwing Up/Spitting Out - Week 4
|
0 Participants
|
0 Participants
|
|
Acceptability of DOR/ISL Tablet
Throwing Up/Spitting Out - Week 24
|
0 Participants
|
0 Participants
|
|
Acceptability of DOR/ISL Tablet
Gagging - Day 1
|
0 Participants
|
0 Participants
|
|
Acceptability of DOR/ISL Tablet
Gagging - Week 4
|
0 Participants
|
0 Participants
|
|
Acceptability of DOR/ISL Tablet
Gagging - Week 24
|
1 Participants
|
0 Participants
|
Adverse Events
DOR/ISL: Virologically Suppressed Cohort
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
DOR/ISL: Treatment Naive Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DOR/ISL: Virologically Suppressed Cohort Extended Monitoring
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
DOR/ISL: Treatment Naive Cohort Extended Monitoring
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 participants at risk
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 participants at risk
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Virologically Suppressed Cohort Extended Monitoring
n=14 participants at risk
VS participants with confirmed protocol-specified decreases in CD4+ T-cell and/or total lymphocyte counts are in extended safety monitoring after switching to non-study ART.
|
DOR/ISL: Treatment Naive Cohort Extended Monitoring
n=1 participants at risk
TN participants with confirmed protocol-specified decreases in CD4+ T-cell and/or total lymphocyte counts are in extended safety monitoring after switching to non-study ART.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
2.7%
1/37 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/14 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
Other adverse events
| Measure |
DOR/ISL: Virologically Suppressed Cohort
n=37 participants at risk
VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Treatment Naive Cohort
n=3 participants at risk
TN participants with HIV-1 infection receive DOR/ISL for 96 weeks.
|
DOR/ISL: Virologically Suppressed Cohort Extended Monitoring
n=14 participants at risk
VS participants with confirmed protocol-specified decreases in CD4+ T-cell and/or total lymphocyte counts are in extended safety monitoring after switching to non-study ART.
|
DOR/ISL: Treatment Naive Cohort Extended Monitoring
n=1 participants at risk
TN participants with confirmed protocol-specified decreases in CD4+ T-cell and/or total lymphocyte counts are in extended safety monitoring after switching to non-study ART.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/14 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
General disorders
Pyrexia
|
5.4%
2/37 • Number of events 2 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
General disorders
Vaccination site pain
|
2.7%
1/37 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.1%
3/37 • Number of events 3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
21.4%
3/14 • Number of events 4 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
2/37 • Number of events 3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • Number of events 2 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • Number of events 2 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Renal and urinary disorders
Proteinuria
|
5.4%
2/37 • Number of events 2 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/14 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
3/37 • Number of events 4 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
28.6%
4/14 • Number of events 7 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.1%
3/37 • Number of events 3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
14.3%
2/14 • Number of events 4 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.8%
4/37 • Number of events 4 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
21.4%
3/14 • Number of events 4 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.4%
2/37 • Number of events 2 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
21.4%
3/14 • Number of events 4 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.4%
2/37 • Number of events 2 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
33.3%
1/3 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/14 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
General disorders
Fatigue
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
General disorders
Injection site pain
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Immune system disorders
Food allergy
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Infections and infestations
COVID-19
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
100.0%
1/1 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Infections and infestations
Ear infection
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Infections and infestations
Varicella
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Investigations
Weight decreased
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 2 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/37 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/3 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
7.1%
1/14 • Number of events 2 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
0.00%
0/1 • Up to approximately 16 months
All-cause mortality was assessed in all randomized participants. Adverse events (AEs) and serious AEs (SAEs) were assessed in all treated participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER