Trial Outcomes & Findings for Dual bNAb Treatment in Children (NCT NCT03707977)
NCT ID: NCT03707977
Last Updated: 2025-05-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Measured until 30 days after study completion for each participant
Results posted on
2025-05-14
Participant Flow
The PK Step was a lead-in to the main study. Twelve participants enrolled in and completed the PK Step (Group PK-A or Group PK-B). Ten of the 12 participants from the PK Groups later enrolled in Step 1, and 18 additional participants who had not participated in the PK Step enrolled in Step 1 for a total of 28 participants to enter Step 1 (and then progress to Step 2 and/or Step 3). Thirty participants enrolled overall in the PK Step and/or the main study.
Participant milestones
| Measure |
Group PK-A: ART + VRC01LS
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
In the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS, Then 10-1074 + VRC01LS Only, Then ART Only)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. Following a recommendation from the study team and Safety Monitoring Committee (SMC) to increase the maintenance dosing based on the PK Step, a VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit.
In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks.
In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
10-1074: Administered by intravenous (IV) infusion
|
|---|---|---|---|
|
PK Step
STARTED
|
6
|
6
|
0
|
|
PK Step
COMPLETED
|
6
|
6
|
0
|
|
PK Step
NOT COMPLETED
|
0
|
0
|
0
|
|
Steps 1 (ART+bNAbs)
STARTED
|
0
|
0
|
28
|
|
Steps 1 (ART+bNAbs)
COMPLETED
|
0
|
0
|
25
|
|
Steps 1 (ART+bNAbs)
NOT COMPLETED
|
0
|
0
|
3
|
|
Step 2 (bNAbs Only)
STARTED
|
0
|
0
|
25
|
|
Step 2 (bNAbs Only)
COMPLETED
|
0
|
0
|
11
|
|
Step 2 (bNAbs Only)
NOT COMPLETED
|
0
|
0
|
14
|
|
Step 3 (Stop bNABs, Resume ART)
STARTED
|
0
|
0
|
28
|
|
Step 3 (Stop bNABs, Resume ART)
COMPLETED
|
0
|
0
|
28
|
|
Step 3 (Stop bNABs, Resume ART)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group PK-A: ART + VRC01LS
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
In the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS, Then 10-1074 + VRC01LS Only, Then ART Only)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. Following a recommendation from the study team and Safety Monitoring Committee (SMC) to increase the maintenance dosing based on the PK Step, a VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit.
In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks.
In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
10-1074: Administered by intravenous (IV) infusion
|
|---|---|---|---|
|
Steps 1 (ART+bNAbs)
HIV-1 RNA >40 copies/mL while receiving ART + bNAbs in Step 1
|
0
|
0
|
3
|
|
Step 2 (bNAbs Only)
HIV-1 RNA >400 copies/mL while receiving bNAbs alone in Step 2
|
0
|
0
|
14
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group PK-B: ART + 10-1074
n=2 Participants
In the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
n=28 Participants
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.12 years
n=2 Participants
|
3.29 years
n=28 Participants
|
3.29 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
19 Participants
n=28 Participants
|
21 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
9 Participants
n=28 Participants
|
9 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Botswana
|
2 participants
n=2 Participants
|
28 participants
n=28 Participants
|
30 participants
n=30 Participants
|
|
Weight
|
12.85 kg
n=2 Participants
|
12.55 kg
n=28 Participants
|
12.55 kg
n=30 Participants
|
|
Height
|
94 cm
n=2 Participants
|
94 cm
n=28 Participants
|
94 cm
n=30 Participants
|
|
CD4 cell count
|
1173 cells/mm^3
n=2 Participants
|
1106 cells/mm^3
n=28 Participants
|
1124 cells/mm^3
n=30 Participants
|
PRIMARY outcome
Timeframe: Measured until 30 days after study completion for each participantOutcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=6 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n=6 Participants
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
n=28 Participants
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade]
|
4 Participants
|
1 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Measured until 30 days after study completion for each participantGraded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with Grade 1 indicating a mild event, Grade 2 indicating a moderate event, Grade 3 indicating a severe event, Grade 4 indicating a potentially life-threatening event, and Grade 5 indicating death.
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=6 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n=6 Participants
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
n=28 Participants
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs)
Number of participants with Grade 3 treatment-associated AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs)
Number of participants with Grade 4 treatment-associated AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs)
Number of participants with Grade 5 treatment-associated AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Week 24 of Step 2Based on laboratory evaluations
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=25 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 400 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART
|
11 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Week 24 of Step 2Based on laboratory evaluations
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=25 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 40 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 12 (PK Step)Median pre-dose trough (28 days post previous dose) based on laboratory evaluations
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=6 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n=6 Participants
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
VRC01LS or 10-1074 Concentrations in Plasma
Day 28
|
223.3 mcg/mL
Interval 157.9 to 253.3
|
155.2 mcg/mL
Interval 91.3 to 318.6
|
—
|
|
VRC01LS or 10-1074 Concentrations in Plasma
Day 56
|
180.7 mcg/mL
Interval 164.9 to 227.1
|
232.0 mcg/mL
Interval 113.6 to 328.5
|
—
|
|
VRC01LS or 10-1074 Concentrations in Plasma
Day 84
|
156.9 mcg/mL
Interval 125.8 to 201.4
|
258.3 mcg/mL
Interval 122.4 to 467.3
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 12 (PK Step)Based on laboratory evaluations
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=6 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n=6 Participants
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose
|
156.9 mcg/mL
Interval 125.8 to 201.4
|
258.3 mcg/mL
Interval 122.4 to 467.3
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 32 following Step 1 entryPopulation: The first 6 participants to enter Step 1 were included in a PK analysis to confirm targets were met with dual bNAb administration. Only these 6 participants had PK measurements at Step 1 Week 8. Twenty-five participants in total contributed PK data but those who discontinued bNAbs early due to HIV-1 RNA \>400 copies/mL had fewer PK measurements.
Based on laboratory evaluations
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=25 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 1 Week 4 (10-1074)
|
154.4 mcg/mL
Interval 83.7 to 257.2
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 1 Week 8 (10-1074)
|
168.1 mcg/mL
Interval 95.5 to 264.7
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 0 (10-1074)
|
194.6 mcg/mL
Interval 120.1 to 417.7
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 4 (10-1074)
|
205.6 mcg/mL
Interval 125.3 to 404.0
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 8 (10-1074)
|
232.3 mcg/mL
Interval 120.3 to 323.2
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 12 (10-1074)
|
211.7 mcg/mL
Interval 111.2 to 371.5
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 16 (10-1074)
|
212.5 mcg/mL
Interval 183.6 to 381.6
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 20 (10-1074)
|
246.8 mcg/mL
Interval 163.5 to 345.8
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 24 or Step 3 Entry (10-1074)
|
268.1 mcg/mL
Interval 108.5 to 1724.1
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 1 Week 4 (VRC01LS)
|
226.5 mcg/mL
Interval 139.0 to 426.3
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 1 Week 8 (VRC01LS)
|
293.4 mcg/mL
Interval 208.0 to 329.9
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 0 (VRC01LS)
|
239.1 mcg/mL
Interval 142.7 to 377.4
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 4 (VRC01LS)
|
255.9 mcg/mL
Interval 124.8 to 370.7
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 8 (VRC01LS)
|
254.7 mcg/mL
Interval 104.7 to 497.8
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 12 (VRC01LS)
|
260.2 mcg/mL
Interval 141.8 to 595.3
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 16 (VRC01LS)
|
273.9 mcg/mL
Interval 141.2 to 673.2
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 20 (VRC01LS)
|
266.5 mcg/mL
Interval 154.2 to 663.9
|
—
|
—
|
|
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Step 2 Week 24 or Step 3 Entry (VRC01LS)
|
295.3 mcg/mL
Interval 170.9 to 507.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 32 following Step 1 entryPopulation: The first 6 participants to enter Step 1 were included in a PK analysis to confirm targets were met with dual bNAb administration. Only these 6 participants had PK measurements at Step 1 Week 8. Twenty-five participants in total contributed PK data but those who discontinued bNAbs early due to HIV-1 RNA \>400 copies/mL had fewer PK measurements.
Based on laboratory evaluations
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=25 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 1 Week 8 (VRC01LS)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 1 Week 4 (VRC01LS)
|
2 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 0 (VRC01LS)
|
4 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 4 (VRC01LS)
|
1 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 8 (VRC01LS)
|
2 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 12 (VRC01LS)
|
2 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 16 (VRC01LS)
|
1 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 20 (VRC01LS)
|
1 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 24 or Step 3 entry (VRC01LS)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 1 Week 4 (10-1074)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 1 Week 8 (10-1074)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 0 (10-1074)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 4 (10-1074)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 8 (10-1074)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 12 (10-1074)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 16 (10-1074)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 20 (10-1074)
|
0 Participants
|
—
|
—
|
|
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Step 2 Week 24 or Step 3 entry (10-1074)
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 24 (Step 3)World Health Organization (WHO) standardized Z-scores will be evaluated for changes over time: WHO Length/height-for-age z-score (0-19 yrs), Change from Step 1, Day 0 to Step 3, Week 24. A z-score of 0 corresponds to the population mean. Scores above 0 indicate a participant's height is above the mean, while a score below 0 indicates a participant's height is below the mean. A positive change in z-score corresponds to a higher z-score at the second timepoint compared to the first.
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=28 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
Height Z-scores of Virally Suppressed Children Receiving bNAbs
|
0.18 change in score on a scale
Interval 0.07 to 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 24 (Step 3)WHO standardized Z-scores will be evaluated for changes over time: WHO Weight-for-age z-score (0-10 yrs), Change from Step 1, Day 0 to Step 3, Week 24. A z-score of 0 corresponds to the population mean. Scores above 0 indicate a participant's weight is above the mean, while a score below 0 indicates a participant's weight is below the mean. A positive change in z-score corresponds to a higher z-score at the second timepoint compared to the first.
Outcome measures
| Measure |
Group PK-A: ART + VRC01LS
n=28 Participants
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
Group PK-B: ART + 10-1074
n the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit. In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks. In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|
|
Weight Z-scores of Virally Suppressed Children Receiving bNAbs
|
0.09 change in score on a scale
Interval 0.04 to 0.22
|
—
|
—
|
Adverse Events
PK Step (ART + VRC01LS)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PK Step (ART + 10-1074)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Step 1 (ART + VRC01LS + 10-1074)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Step 2 (VRC01LS + 10-1074 Only)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Step 3 (ART Only)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PK Step (ART + VRC01LS)
n=6 participants at risk
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
PK Step (ART + 10-1074)
n=6 participants at risk
In the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Step 1 (ART + VRC01LS + 10-1074)
n=28 participants at risk
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit.
|
Step 2 (VRC01LS + 10-1074 Only)
n=25 participants at risk
In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks.
|
Step 3 (ART Only)
n=28 participants at risk
In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
Other adverse events
| Measure |
PK Step (ART + VRC01LS)
n=6 participants at risk
In the PK Step, participants will continue ART and receive VRC01LS at Weeks 0, 4, and 8 as a single intravenous (IV) dose (30 mg/kg load then 10 mg/kg maintenance).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
VRC01LS: Administered by intravenous (IV) infusion
|
PK Step (ART + 10-1074)
n=6 participants at risk
In the PK Step, participants will continue ART and receive 10-1074 at Weeks 0, 4, and 8 as a single IV dose (30 mg/kg).
ART: ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
10-1074: Administered by intravenous (IV) infusion
|
Step 1 (ART + VRC01LS + 10-1074)
n=28 participants at risk
In Step 1, eligible participants will continue to receive ART and will receive both 10-1074 and VRC01LS at Weeks 0, 4, and 8. A VRC01LS loading dose of 30 mg/kg will be given at the start of Step 1, followed by 15 mg/kg dosing at each 4-weekly visit, and 10-1074 dosing will be at 30 mg/kg at each 4-weekly visit.
|
Step 2 (VRC01LS + 10-1074 Only)
n=25 participants at risk
In Step 2, participants with ongoing viral suppression throughout Step 1 will undergo withdrawal of ART and will continue maintenance 10-1074 (30 mg/kg) and VRC01LS (15 mg/kg) treatment for up to 24 weeks.
|
Step 3 (ART Only)
n=28 participants at risk
In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Eye disorders
Eye discharge
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
8.0%
2/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
10.7%
3/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
8.0%
2/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
10.7%
3/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
General disorders
Chills
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
50.0%
3/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
24.0%
6/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Abscess limb
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Body tinea
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Conjunctivitis
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
10.7%
3/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
50.0%
3/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
12.0%
3/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Tinea capitis
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
8.0%
2/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Tinea manuum
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
17.9%
5/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
32.0%
8/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
25.0%
7/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Viral rash
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Injury, poisoning and procedural complications
Buttock injury
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
8.0%
2/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Blood calcium increased
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Blood glucose decreased
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
17.9%
5/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
20.0%
5/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Blood glucose increased
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Blood pressure increased
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
10.7%
3/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
20.0%
5/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Haemoglobin decreased
|
66.7%
4/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
28.6%
8/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
28.0%
7/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
50.0%
14/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
35.7%
10/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.0%
4/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
28.6%
8/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
8.0%
2/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
83.3%
5/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
50.0%
3/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
25.0%
7/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
44.0%
11/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
39.3%
11/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
8.0%
2/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
83.3%
5/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
17.9%
5/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
28.0%
7/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
28.6%
8/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
4.0%
1/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
21.4%
6/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
7.1%
2/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
16.7%
1/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/6 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
0.00%
0/25 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
3.6%
1/28 • Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
|
Additional Information
Molly Pretorius Holme
Harvard T.H. Chan School of Public Health
Phone: 617-432-4377
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place