Phase 2
Completed N=12
Dual bNAb Treatment in Children
Source: ClinicalTrials.gov NCT03707977 ↗Enrolled (actual)
12
Serious AEs
1.1%
Results posted
Feb 2023
Primary outcomePrimary: Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade] — 4; 1; 19 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Treatment-associated Adverse Events (AEs) [Number of Participants With Treatment-associated Adverse Event(s) of Any Grade] |
4; 1; 19 | — |
| PRIMARY Severity of Treatment-associated AEs (Number of Participants With Grade 3 or Higher Related AEs) |
0; 0; 1; 0; 0; 0 | — |
| 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 |
11 | — |
| 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 |
10 | — |
| SECONDARY VRC01LS or 10-1074 Concentrations in Plasma |
223.3; 155.2; 180.7; 232.0; 156.9; 258.3 | — |
| SECONDARY Median Trough Concentration of VRC01LS or 10-1074 in Plasma 28 Days After the Third Dose |
156.9; 258.3 | — |
| SECONDARY VRC01LS and 10-1074 Concentrations in Plasma for Each Time Point |
154.4; 168.1; 194.6; 205.6; 232.3; 211.7 | — |
| SECONDARY Proportion of Children With Trough VRC01LS and 10-1074 Concentrations Below Defined Trough Ranges |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Height Z-scores of Virally Suppressed Children Receiving bNAbs |
0.18 | — |
| SECONDARY Weight Z-scores of Virally Suppressed Children Receiving bNAbs |
0.09 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03707977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.