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| ID | Type | Description | Link |
|---|---|---|---|
| 38551 | Registry Identifier | DAIDS-ES Registry Number |
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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.
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:
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 In Step 2, ART is withdrawn and dual bNAb maintenance treatment occurs.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group PK-A: ART + VRC01LS | Experimental | 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). |
|
| Group PK-B: ART + 10-1074 | Experimental | 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). |
|
| Steps 1-3 Participants (ART + 10-1074 + VRC01LS) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ART | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | Measured until 30 days after study completion for each participant |
| 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 | Measured through Week 24 of Step 2 |
| 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 | Measured through Week 24 of Step 2 |
| Measure | Description | Time Frame |
|---|---|---|
| VRC01LS or 10-1074 Concentrations in Plasma | Median pre-dose trough (28 days post previous dose) based on laboratory evaluations | Measured through Week 12 (PK Step) |
| Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose |
Not provided
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)
Inclusion Criteria for Entry into Step 1 (followed by participation in Steps 2-3):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Shapiro, MD, MPH | Harvard School of Public Health (HSPH) | Principal Investigator |
| Daniel Kuritzkes, MD | Brigham and Women's Hospital | Principal Investigator |
| Mathias Lichterfeld, MD, PhD | Brigham and Women's Hospital/Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francistown Non-Network CRS | Francistown | Botswana | ||||
| Botswana Harvard AIDS Institute Partnership CRS Non-Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094485 | Result | Capparelli EV, Ajibola G, Maswabi K, Holme MP, Bennett K, Powis KM, Moyo S, Mohammed T, Maphorisa C, Hughes MD, Seaton KE, Tomaras GD, Mosher S, Taylor A, O'Connell S, Narpala S, Mcdermott A, Caskey M, Gama L, Lockman S, Jean-Philippe P, Makhema J, Kuritzkes DR, Lichterfeld M, Shapiro RL; Tatelo Study Team. Safety and Pharmacokinetics of Intravenous 10-1074 and VRC01LS in Young Children. J Acquir Immune Defic Syndr. 2022 Oct 1;91(2):182-188. doi: 10.1097/QAI.0000000000003033. | |
| 37406137 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PK Step |
| |||||||||||||
| Steps 1 (ART+bNAbs) |
| |||||||||||||
| Step 2 (bNAbs Only) |
| |||||||||||||
| Step 3 (Stop bNABs, Resume ART) |
|
2 participants who entered the PK Step (a lead-in to the main study) in Group B did not proceed to Step 1 due to ineligibility for Step 1. Baseline characteristics of these 2 participants are reported separately. Baseline characteristics (at the time of study entry) for all 28 other participants (including those who entered the study in the PK Step and proceeded to Step 1) are shown in the Steps 1-3 group results.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at study entry |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade] | Posted | Count of Participants | Participants | Measured until 30 days after study completion for each participant |
|
Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PK Step (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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Molly Pretorius Holme | Harvard T.H. Chan School of Public Health | 617-432-4377 | mpretori@hsph.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2021 | Nov 16, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2022 | Nov 16, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: PK Step | Dec 20, 2018 | Nov 16, 2022 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Steps 1 to 3 | May 19, 2020 | Nov 16, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
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| VRC01LS | Biological | Administered by intravenous (IV) infusion |
|
| 10-1074 | Biological | Administered by intravenous (IV) infusion |
|
Based on laboratory evaluations |
| Measured through Week 12 (PK Step) |
| VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Based on laboratory evaluations | Measured through Week 32 following Step 1 entry |
| Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Based on laboratory evaluations | Measured through Week 32 following Step 1 entry |
| 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. | Measured through Week 24 (Step 3) |
| 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. | Measured through Week 24 (Step 3) |
| Gaborone |
| Botswana |
| Result |
| Shapiro RL, Ajibola G, Maswabi K, Hughes M, Nelson BS, Niesar A, Pretorius Holme M, Powis KM, Sakoi M, Batlang O, Moyo S, Mohammed T, Maphorisa C, Bennett K, Hu Z, Giguel F, Reeves JD, Reeves MA, Gao C, Yu X, Ackerman ME, McDermott A, Cooper M, Caskey M, Gama L, Jean-Philippe P, Yin DE, Capparelli EV, Lockman S, Makhema J, Kuritzkes DR, Lichterfeld M. Broadly neutralizing antibody treatment maintained HIV suppression in children with favorable reservoir characteristics in Botswana. Sci Transl Med. 2023 Jul 5;15(703):eadh0004. doi: 10.1126/scitranslmed.adh0004. Epub 2023 Jul 5. |
| 40136003 | Result | Banga J, Nelson BS, Ajibola G, Mohammed T, Maphorisa C, Boleo C, Moyo S, Batlang O, Sakoi-Mosetlhi M, Maswabi K, Holme MP, Powis KM, Lockman S, Hughes MD, Makhema J, Kuritzkes DR, Litcherfeld M, Shapiro R. Predictive markers for sustained viral suppression on dual bNAbs during ART interruption in children. J Acquir Immune Defic Syndr. 2025 Mar 26:10.1097/QAI.0000000000003663. doi: 10.1097/QAI.0000000000003663. Online ahead of print. |
| 38536810 | Result | Sakoi-Mosetlhi M, Ajibola G, Haghighat R, Batlang O, Maswabi K, Pretorius-Holme M, Powis KM, Lockman S, Makhema J, Litcherfeld M, Kuritzkes DR, Shapiro R. Caregivers of children with HIV in Botswana prefer monthly IV Broadly Neutralizing Antibodies (bNAbs) to daily oral ART. PLoS One. 2024 Mar 27;19(3):e0299942. doi: 10.1371/journal.pone.0299942. eCollection 2024. |
| 41697750 | Result | Niesar A, Lancien M, Hong S, Naasz C, Ajibola G, Maswabi K, Sakoi-Mosetlhi M, Batlang O, Moyo S, Mohammed T, Maphorisa C, Carrere L, Roseto I, Hartana CA, Tan TS, Gao C, Parsons E, Hua R, Pretorius Holme M, Lockman S, Powis KM, Carrington M, Makhema J, Yu XG, Kuritzkes DR, Shapiro RL, Lichterfeld M. Immune correlates of HIV-1 rebound during broadly neutralizing antibody treatment in young children. J Clin Invest. 2026 Feb 16;136(4):e193912. doi: 10.1172/JCI193912. eCollection 2026 Feb 16. |
| 41078080 | Result | Ajibola G, Nelson BS, Niesar A, Hong S, Lancien M, Holme MP, Hughes MD, Yin DE, Jean-Philippe P, Moyo S, Batlang O, Sakoi M, Maphorisa C, Mohammed T, Lockman S, Makhema J, Kuritzkes DR, Lichterfeld M, Shapiro RL. Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study. Clin Infect Dis. 2026 Feb 25;82(2):e278-e285. doi: 10.1093/cid/ciaf568. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Weight at study entry | Median | Inter-Quartile Range | kg |
|
| Height | Height at study entry | Median | Inter-Quartile Range | cm |
|
| CD4 cell count | CD4 cell count at study entry | Median | Inter-Quartile Range | cells/mm^3 |
|
| OG002 | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | Measured until 30 days after study completion for each participant |
|
|
|
| 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 | Posted | Count of Participants | Participants | Measured through Week 24 of Step 2 |
|
|
|
| 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 | Posted | Count of Participants | Participants | Measured through Week 24 of Step 2 |
|
|
|
| Secondary | VRC01LS or 10-1074 Concentrations in Plasma | Median pre-dose trough (28 days post previous dose) based on laboratory evaluations | Posted | Median | Full Range | mcg/mL | Measured through Week 12 (PK Step) |
|
|
|
| Secondary | Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose | Based on laboratory evaluations | Posted | Median | Full Range | mcg/mL | Measured through Week 12 (PK Step) |
|
|
|
| Secondary | VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point | Based on laboratory evaluations | 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. | Posted | Median | Full Range | mcg/mL | Measured through Week 32 following Step 1 entry |
|
|
|
| Secondary | Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges | Based on laboratory evaluations | 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. | Posted | Count of Participants | Participants | Measured through Week 32 following Step 1 entry |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | change in score on a scale | Measured through Week 24 (Step 3) |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | change in score on a scale | Measured through Week 24 (Step 3) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | PK Step (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 | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Step 1 (ART + VRC01LS + 10-1074) | 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. | 0 | 28 | 0 | 28 | 23 | 28 |
| EG003 | Step 2 (VRC01LS + 10-1074 Only) | 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. | 0 | 25 | 1 | 25 | 18 | 25 |
| EG004 | Step 3 (ART Only) | In Step 3, both 10-1074 and VRC01LS will be discontinued and ART will be re-started. | 0 | 28 | 0 | 28 | 26 | 28 |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Ear swelling | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Swelling of eyelid | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Purulent discharge | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Skin bacterial infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Tinea capitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Tinea manuum | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Buttock injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Skin wound | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Carbon dioxide decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Acquired phimosis | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Penile pain | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Skin plaque | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
| Number of participants with Grade 5 treatment-associated AEs |
|
| Day 84 |
|
|
| Step 2 Week 0 (10-1074) |
|
|
| Step 2 Week 4 (10-1074) |
|
|
| Step 2 Week 8 (10-1074) |
|
|
| Step 2 Week 12 (10-1074) |
|
|
| Step 2 Week 16 (10-1074) |
|
|
| Step 2 Week 20 (10-1074) |
|
|
| Step 2 Week 24 or Step 3 Entry (10-1074) |
|
|
| Step 1 Week 4 (VRC01LS) |
|
|
| Step 1 Week 8 (VRC01LS) |
|
|
| Step 2 Week 0 (VRC01LS) |
|
|
| Step 2 Week 4 (VRC01LS) |
|
|
| Step 2 Week 8 (VRC01LS) |
|
|
| Step 2 Week 12 (VRC01LS) |
|
|
| Step 2 Week 16 (VRC01LS) |
|
|
| Step 2 Week 20 (VRC01LS) |
|
|
| Step 2 Week 24 or Step 3 Entry (VRC01LS) |
|
|
|
| Step 2 Week 0 (10-1074) |
|
|
| Step 2 Week 4 (10-1074) |
|
|
| Step 2 Week 8 (10-1074) |
|
|
| Step 2 Week 12 (10-1074) |
|
|
| Step 2 Week 16 (10-1074) |
|
|
| Step 2 Week 20 (10-1074) |
|
|
| Step 2 Week 24 or Step 3 entry (10-1074) |
|
|
| Step 1 Week 4 (VRC01LS) |
|
|
| Step 1 Week 8 (VRC01LS) |
|
|
| Step 2 Week 0 (VRC01LS) |
|
|
| Step 2 Week 4 (VRC01LS) |
|
|
| Step 2 Week 8 (VRC01LS) |
|
|
| Step 2 Week 12 (VRC01LS) |
|
|
| Step 2 Week 16 (VRC01LS) |
|
|
| Step 2 Week 20 (VRC01LS) |
|
|
| Step 2 Week 24 or Step 3 entry (VRC01LS) |
|
|