Dual bNAb Treatment in Children

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Antibodies; Antibodies, Blocking; Immunoglobulins

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)