HIV Infection
Conditions
Keywords
broadly neutralizing antibodies, HIV suppression
Brief summary
The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana.
Detailed description
This study will evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana. The primary objectives are as follows: 1. To conduct an interventional clinical trial to determine the safety, pharmacokinetics, dosing and antiviral efficacy of up to 24 weeks of maintenance VRC01LS and 10-1074 immunotherapy in early-treated HIV-1 infected children in Botswana. 2. To evaluate effects of treatment with VRC01LS and 10-1074 on the size and cellular composition of residual viral reservoirs. 3. To investigate the influence of VRC01LS and 10-1074 treatment on the magnitude and quality of antiviral innate and adaptive immune responses. The study includes 4 steps: the pharmacokinetics (PK) Step, Step 1, Step 2, and Step 3. In the PK Step, antiretroviral treatment (ART) is continued and 12 study participants will undergo safety and PK testing, 6 for each bNAb used in the study (10-1074 and VRC01LS). In Step 1, ART is continued and dual bNAb treatment occurs, with PK confirmation of dual bNAb dosing for the first 6 participants in Step 1. In Step 2, ART is withdrawn and dual bNAb maintenance treatment occurs. In Step 3, dual bNAbs will be discontinued and participants will be re-started on ART. Participants will be in the study for a minimum of 56 weeks, and a maximum of 98 weeks for those who start in the PK step and continue through the study.
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
96 Weeks to 7 Years
Healthy volunteers
No
Inclusion criteria
for PK Step\*: * On ART for at least 96 weeks * Greater than or equal to 96 weeks and less than 5 years of age at enrollment * HIV RNA less than 40 copies/mL for at least 24 weeks prior to entry * Ability to remain in close study follow-up for at least 12 weeks * Willingness to receive IV infusions of bNAbs * Willingness to provide signed informed consent (by the parent/guardian) * \*It is anticipated that all children in PK Step will be from Early Infant Treatment (EIT) Study (NCT02369406); however, up to 4 HIV+ children outside the PK Study (age range 2-5 years) may participate in the PK Step if otherwise eligible and if EIT children are unavailable. Inclusion Criteria for Entry into Step 1 (followed by participation in Steps 2-3): * EIT Study participant (NCT02369406) * On ART for at least 96 weeks * Greater than or equal to 96 weeks and less than 7 years of age at enrollment * HIV RNA less than 40 copies/mL for at least 24 weeks prior to entry * Ability to remain in close study follow-up for at least 56 weeks * Willingness to receive IV infusions of bNAbs * Willingness to provide signed informed consent (by the parent/guardian)
Exclusion criteria
* Medical condition making survival for at least 32 weeks unlikely * Active tuberculosis or malignancy * Actively breastfeeding * Previous receipt of VRC01/VRC01LS or 10-1074 (except during the PK Step)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade] | Measured until 30 days after study completion for each participant | — |
| Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs) | Measured until 30 days after study completion for each participant | Graded 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. |
| Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 400 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART | Measured through Week 24 of Step 2 | Based on laboratory evaluations |
| Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 40 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART | Measured through Week 24 of Step 2 | Based on laboratory evaluations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height Z-scores of Virally Suppressed Children Receiving bNAbs | 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. |
| VRC01LS or 10-1074 Concentrations in Plasma | Measured through Week 12 (PK Step) | Median pre-dose trough (28 days post previous dose) based on laboratory evaluations |
| Weight Z-scores of Virally Suppressed Children Receiving bNAbs | 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. |
| Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose | Measured through Week 12 (PK Step) | Based on laboratory evaluations |
| VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Measured through Week 32 following Step 1 entry | Based on laboratory evaluations |
| Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Measured through Week 32 following Step 1 entry | Based on laboratory evaluations |
Countries
Botswana
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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. | 28 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Step 2 (bNAbs Only) | HIV-1 RNA >400 copies/mL while receiving bNAbs alone in Step 2 | 0 | 0 | 14 |
| Steps 1 (ART+bNAbs) | HIV-1 RNA >40 copies/mL while receiving ART + bNAbs in Step 1 | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Group PK-B: ART + 10-1074 | Steps 1-3 Participants (ART + 10-1074 + VRC01LS) | Total |
|---|---|---|---|
| Age, Continuous | 3.12 years | 3.29 years | 3.29 years |
| CD4 cell count | 1173 cells/mm^3 | 1106 cells/mm^3 | 1124 cells/mm^3 |
| Height | 94 cm | 94 cm | 94 cm |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Botswana | 2 participants | 28 participants | 30 participants |
| Sex: Female, Male Female | 2 Participants | 19 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 9 Participants | 9 Participants |
| Weight | 12.85 kg | 12.55 kg | 12.55 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 28 | 0 / 25 | 0 / 28 |
| other Total, other adverse events | 5 / 6 | 6 / 6 | 23 / 28 | 18 / 25 | 26 / 28 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 28 | 1 / 25 | 0 / 28 |
Outcome results
Primary
Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade]
Time frame: Measured until 30 days after study completion for each participant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group PK-A: ART + VRC01LS | Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade] | 4 Participants |
| Group PK-B: ART + 10-1074 | Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade] | 1 Participants |
| Steps 1-3 Participants (ART + 10-1074 + VRC01LS) | Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade] | 19 Participants |
Primary
Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 400 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART
Based on laboratory evaluations
Time frame: Measured through Week 24 of Step 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group PK-A: ART + VRC01LS | 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
Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 40 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART
Based on laboratory evaluations
Time frame: Measured through Week 24 of Step 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group PK-A: ART + VRC01LS | 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 |
Primary
Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs)
Graded 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.
Time frame: Measured until 30 days after study completion for each participant
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group PK-A: ART + VRC01LS | 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 |
| Group PK-A: ART + VRC01LS | 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 |
| Group PK-A: ART + VRC01LS | 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 |
| Group PK-B: ART + 10-1074 | 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 |
| Group PK-B: ART + 10-1074 | 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 |
| Group PK-B: ART + 10-1074 | 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 |
| Steps 1-3 Participants (ART + 10-1074 + VRC01LS) | Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs) | Number of participants with Grade 3 treatment-associated AEs | 1 Participants |
| Steps 1-3 Participants (ART + 10-1074 + VRC01LS) | 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 |
| Steps 1-3 Participants (ART + 10-1074 + VRC01LS) | 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 |
Secondary
Height Z-scores of Virally Suppressed Children Receiving bNAbs
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.
Time frame: Measured through Week 24 (Step 3)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group PK-A: ART + VRC01LS | Height Z-scores of Virally Suppressed Children Receiving bNAbs | 0.18 change in score on a scale |
Secondary
Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose
Based on laboratory evaluations
Time frame: Measured through Week 12 (PK Step)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group PK-A: ART + VRC01LS | Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose | 156.9 mcg/mL |
| Group PK-B: ART + 10-1074 | Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose | 258.3 mcg/mL |
Secondary
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
Based on laboratory evaluations
Time frame: Measured through Week 32 following Step 1 entry
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 1 Week 4 (10-1074) | 0 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 1 Week 8 (10-1074) | 0 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 0 (10-1074) | 0 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 4 (10-1074) | 0 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 8 (10-1074) | 0 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 12 (10-1074) | 0 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 16 (10-1074) | 0 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 20 (10-1074) | 0 Participants |
| Group PK-A: ART + VRC01LS | 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 |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 1 Week 4 (VRC01LS) | 2 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 1 Week 8 (VRC01LS) | 0 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 0 (VRC01LS) | 4 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 4 (VRC01LS) | 1 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 8 (VRC01LS) | 2 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 12 (VRC01LS) | 2 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 16 (VRC01LS) | 1 Participants |
| Group PK-A: ART + VRC01LS | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Step 2 Week 20 (VRC01LS) | 1 Participants |
| Group PK-A: ART + VRC01LS | 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 |
Secondary
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
Based on laboratory evaluations
Time frame: Measured through Week 32 following Step 1 entry
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 1 Week 4 (10-1074) | 154.4 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 1 Week 8 (10-1074) | 168.1 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 0 (10-1074) | 194.6 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 4 (10-1074) | 205.6 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 8 (10-1074) | 232.3 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 12 (10-1074) | 211.7 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 16 (10-1074) | 212.5 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 20 (10-1074) | 246.8 mcg/mL |
| Group PK-A: ART + VRC01LS | 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 |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 1 Week 4 (VRC01LS) | 226.5 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 1 Week 8 (VRC01LS) | 293.4 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 0 (VRC01LS) | 239.1 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 4 (VRC01LS) | 255.9 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 8 (VRC01LS) | 254.7 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 12 (VRC01LS) | 260.2 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 16 (VRC01LS) | 273.9 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 20 (VRC01LS) | 266.5 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Step 2 Week 24 or Step 3 Entry (VRC01LS) | 295.3 mcg/mL |
Secondary
VRC01LS or 10-1074 Concentrations in Plasma
Median pre-dose trough (28 days post previous dose) based on laboratory evaluations
Time frame: Measured through Week 12 (PK Step)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group PK-A: ART + VRC01LS | VRC01LS or 10-1074 Concentrations in Plasma | Day 28 | 223.3 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS or 10-1074 Concentrations in Plasma | Day 56 | 180.7 mcg/mL |
| Group PK-A: ART + VRC01LS | VRC01LS or 10-1074 Concentrations in Plasma | Day 84 | 156.9 mcg/mL |
| Group PK-B: ART + 10-1074 | VRC01LS or 10-1074 Concentrations in Plasma | Day 28 | 155.2 mcg/mL |
| Group PK-B: ART + 10-1074 | VRC01LS or 10-1074 Concentrations in Plasma | Day 56 | 232.0 mcg/mL |
| Group PK-B: ART + 10-1074 | VRC01LS or 10-1074 Concentrations in Plasma | Day 84 | 258.3 mcg/mL |
Secondary
Weight Z-scores of Virally Suppressed Children Receiving bNAbs
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.
Time frame: Measured through Week 24 (Step 3)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group PK-A: ART + VRC01LS | Weight Z-scores of Virally Suppressed Children Receiving bNAbs | 0.09 change in score on a scale |