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CompletedNCT03707977Updated May 4, 2026Results posted

Dual bNAb Treatment in Children

A Phase 1/2 interventional study of ART and VRC01LS in HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in Botswana. Open to participants aged 96 Weeks to 7 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
96 Weeks to 7 Years
Sex
All
01

Study 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.

Read the 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 In Step 2, ART is withdrawn and dual bNAb maintenance treatment occurs.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.

02

Conditions studied

  • HIV Infection

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Keywords

  • broadly neutralizing antibodies
  • HIV suppression
03

Who can participate

Ages eligible
96 Weeks to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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)
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    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).

    Drug: ART · Biological: VRC01LS

  • Experimental
    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).

    Drug: ART · Biological: 10-1074

  • Experimental
    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. 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.

    Drug: ART · Biological: VRC01LS · Biological: 10-1074

Interventions

  • DrugART

    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.

  • BiologicalVRC01LS

    Administered by intravenous (IV) infusion

  • Biological10-1074

    Administered by intravenous (IV) infusion

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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)

  6. 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)

06

Results

Posted Feb 14, 2023

Participant flow

PK Step
Participant flow — PK Step
MilestoneGroup PK-A: ART + VRC01LSGroup PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS, Then 10-1074 + VRC01LS Only, Then ART Only)
Started660
Completed660
Not completed000
Steps 1 (ART+bNAbs)
Participant flow — Steps 1 (ART+bNAbs)
MilestoneGroup PK-A: ART + VRC01LSGroup PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS, Then 10-1074 + VRC01LS Only, Then ART Only)
Started0028
Completed0025
Not completed003
Withdrew: Hiv-1 rna >40 copies/ml while receiving art + bnabs in step 1003
Step 2 (bNAbs Only)
Participant flow — Step 2 (bNAbs Only)
MilestoneGroup PK-A: ART + VRC01LSGroup PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS, Then 10-1074 + VRC01LS Only, Then ART Only)
Started0025
Completed0011
Not completed0014
Withdrew: Hiv-1 rna >400 copies/ml while receiving bnabs alone in step 20014
Step 3 (Stop bNABs, Resume ART)
Participant flow — Step 3 (Stop bNABs, Resume ART)
MilestoneGroup PK-A: ART + VRC01LSGroup PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS, Then 10-1074 + VRC01LS Only, Then ART Only)
Started0028
Completed0028
Not completed000

Outcome measures

PrimaryFrequency 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
Reported as:
Count of participants · Participants
Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade]
ParticipantsGroup PK-A: ART + VRC01LSGroup PK-B: ART + 10-1074Steps 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]4119
PrimarySeverity 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
Reported as:
Count of participants · Participants
Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs)
ParticipantsGroup PK-A: ART + VRC01LSGroup PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS)
Number of participants with Grade 3 treatment-associated AEs001
Number of participants with Grade 4 treatment-associated AEs000
Number of participants with Grade 5 treatment-associated AEs000
PrimaryProportion 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
Reported as:
Count of participants · Participants
Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 400 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART
ParticipantsSteps 2 Participants (10-1074 + VRC01LS)
Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 400 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART11
PrimaryProportion 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
Reported as:
Count of participants · Participants
Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 40 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART
ParticipantsSteps 2 Participants (10-1074 + VRC01LS)
Proportion of Children Who Maintain HIV-1 Plasma RNA Less Than 40 Copies/mL, After Initiating VRC01LS and 10-1074 Infusions and Stopping ART10
SecondaryVRC01LS 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)
Reported as:
Median · mcg/mL
VRC01LS or 10-1074 Concentrations in Plasma
mcg/mLGroup PK-A: ART + VRC01LSGroup PK-B: ART + 10-1074
Day 28223.3 (157.9 to 253.3)155.2 (91.3 to 318.6)
Day 56180.7 (164.9 to 227.1)232.0 (113.6 to 328.5)
Day 84156.9 (125.8 to 201.4)258.3 (122.4 to 467.3)
SecondaryMedian 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)
Reported as:
Median · mcg/mL
Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose
mcg/mLGroup PK-A: ART + VRC01LSGroup PK-B: ART + 10-1074
Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose156.9 (125.8 to 201.4)258.3 (122.4 to 467.3)
SecondaryVRC01LS and 10-1074 Concentrations in Plasma for Each Time Point

Based on laboratory evaluations

Time frame:
Measured through Week 32 following Step 1 entry
Reported as:
Median · mcg/mL
VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point
mcg/mLSteps 1-3 Participants (ART + 10-1074 + VRC01LS)
Step 1 Week 4 (10-1074)154.4 (83.7 to 257.2)
Step 1 Week 8 (10-1074)168.1 (95.5 to 264.7)
Step 2 Week 0 (10-1074)194.6 (120.1 to 417.7)
Step 2 Week 4 (10-1074)205.6 (125.3 to 404)
Step 2 Week 8 (10-1074)232.3 (120.3 to 323.2)
Step 2 Week 12 (10-1074)211.7 (111.2 to 371.5)
Step 2 Week 16 (10-1074)212.5 (183.6 to 381.6)
Step 2 Week 20 (10-1074)246.8 (163.5 to 345.8)
Step 2 Week 24 or Step 3 Entry (10-1074)268.1 (108.5 to 1724.1)
Step 1 Week 4 (VRC01LS)226.5 (139 to 426.3)
Step 1 Week 8 (VRC01LS)293.4 (208 to 329.9)
Step 2 Week 0 (VRC01LS)239.1 (142.7 to 377.4)
Step 2 Week 4 (VRC01LS)255.9 (124.8 to 370.7)
Step 2 Week 8 (VRC01LS)254.7 (104.7 to 497.8)
Step 2 Week 12 (VRC01LS)260.2 (141.8 to 595.3)
Step 2 Week 16 (VRC01LS)273.9 (141.2 to 673.2)
Step 2 Week 20 (VRC01LS)266.5 (154.2 to 663.9)
Step 2 Week 24 or Step 3 Entry (VRC01LS)295.3 (170.9 to 507.8)
SecondaryProportion 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
Reported as:
Count of participants · Participants
Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges
ParticipantsSteps 1-3 Participants (ART + 10-1074 + VRC01LS)
Step 1 Week 4 (10-1074)0
Step 1 Week 8 (10-1074)0
Step 2 Week 0 (10-1074)0
Step 2 Week 4 (10-1074)0
Step 2 Week 8 (10-1074)0
Step 2 Week 12 (10-1074)0
Step 2 Week 16 (10-1074)0
Step 2 Week 20 (10-1074)0
Step 2 Week 24 or Step 3 entry (10-1074)0
Step 1 Week 4 (VRC01LS)2
Step 1 Week 8 (VRC01LS)0
Step 2 Week 0 (VRC01LS)4
Step 2 Week 4 (VRC01LS)1
Step 2 Week 8 (VRC01LS)2
Step 2 Week 12 (VRC01LS)2
Step 2 Week 16 (VRC01LS)1
Step 2 Week 20 (VRC01LS)1
Step 2 Week 24 or Step 3 entry (VRC01LS)0
SecondaryHeight 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)
Reported as:
Mean · change in score on a scale
Height Z-scores of Virally Suppressed Children Receiving bNAbs
change in score on a scaleSteps 1-3 Participants (ART + 10-1074 + VRC01LS)
Height Z-scores of Virally Suppressed Children Receiving bNAbs0.18 (0.07 to 0.30)
SecondaryWeight 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)
Reported as:
Mean · change in score on a scale
Weight Z-scores of Virally Suppressed Children Receiving bNAbs
change in score on a scaleSteps 1-3 Participants (ART + 10-1074 + VRC01LS)
Weight Z-scores of Virally Suppressed Children Receiving bNAbs0.09 (0.04 to 0.22)

Adverse events

Collected over Measured until 30 days after study completion for each participant. Each column reports events occurring during that specific step.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PK Step (ART + VRC01LS)0/6 (0%)0/6 (0%)5/6 (83.3%)
PK Step (ART + 10-1074)0/6 (0%)0/6 (0%)6/6 (100%)
Step 1 (ART + VRC01LS + 10-1074)0/28 (0%)0/28 (0%)23/28 (82.1%)
Step 2 (VRC01LS + 10-1074 Only)0/25 (0%)1/25 (4%)18/25 (72%)
Step 3 (ART Only)0/28 (0%)0/28 (0%)26/28 (92.9%)
Most frequent serious events
Most frequent serious events
EventPK Step (ART + VRC01LS)PK Step (ART + 10-1074)Step 1 (ART + VRC01LS + 10-1074)Step 2 (VRC01LS + 10-1074 Only)Step 3 (ART Only)
PneumoniaInfections and infestations0/60/60/281/250/28
Most frequent other events
Showing 10 of 84
Most frequent other events
EventPK Step (ART + VRC01LS)PK Step (ART + 10-1074)Step 1 (ART + VRC01LS + 10-1074)Step 2 (VRC01LS + 10-1074 Only)Step 3 (ART Only)
CoughRespiratory, thoracic and mediastinal disorders5/63/67/2811/2511/28
RhinorrhoeaRespiratory, thoracic and mediastinal disorders1/65/65/287/258/28
Haemoglobin decreasedInvestigations4/62/68/287/2514/28
PyrexiaGeneral disorders2/63/61/286/251/28
RhinitisInfections and infestations1/63/62/283/252/28
Neutrophil count decreasedInvestigations1/61/610/284/258/28
Abdominal painGastrointestinal disorders2/61/61/280/251/28
Viral upper respiratory tract infectionInfections and infestations2/61/60/280/250/28
Blood glucose decreasedInvestigations0/62/65/285/251/28
Blood sodium decreasedInvestigations0/62/63/285/252/28

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)Group PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS)Total
Median3.12 (2.13 to 4.10)3.29 (2.80 to 3.98)3.29 (2.70 to 4.10)
Sex: Female, Male
Sex: Female, Male(Participants)Group PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS)Total
Female21921
Male099
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Group PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS)Total
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Group PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS)Total
Botswana22830
Weight
Weight(kg)Group PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS)Total
Median12.85 (10.30 to 15.40)12.55 (11.00 to 14.65)12.55 (10.90 to 15.20)
Height
Height(cm)Group PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS)Total
Median94 (85 to 103)94 (87.5 to 101.5)94 (87 to 102)
CD4 cell count
CD4 cell count(cells/mm^3)Group PK-B: ART + 10-1074Steps 1-3 Participants (ART + 10-1074 + VRC01LS)Total
Median1173 (1131 to 1215)1106 (795 to 1539)1124 (833 to 1408)
07

Study locations

2 sites
  • Francistown Non-Network CRS
    Francistown, Botswana
  • Botswana Harvard AIDS Institute Partnership CRS Non-Network
    Gaborone, Botswana
08

References and documents

Publications

  • 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. PubMed 36094485 ↗
  • 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. PubMed 37406137 ↗
  • 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. PubMed 40136003 ↗
  • 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. PubMed 38536810 ↗
  • 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. PubMed 41697750 ↗
  • 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. PubMed 41078080 ↗

Study documents

  • Study protocol · Jul 19, 2021
  • Statistical analysis plan · Sep 27, 2022
  • Informed consent form · Dec 20, 2018
  • Informed consent form · May 19, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03707977
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Oct 16, 2018
Start date
Jun 17, 2019
Primary completion
Dec 3, 2021
Completion
Dec 3, 2021
Results posted
Feb 14, 2023
Last update
May 4, 2026

Study contacts

Roger Shapiro, MD, MPH
principal investigator · Harvard School of Public Health (HSPH)
Daniel Kuritzkes, MD
principal investigator · Brigham and Women's Hospital
Mathias Lichterfeld, MD, PhD
principal investigator · Brigham and Women's Hospital/Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

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Other studies from this sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

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