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Dual bNAb Treatment in Children

NCT03707977 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-04

Study results available
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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.

Conditions

  • HIV Infection

Interventions

DRUG

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.

BIOLOGICAL

VRC01LS

Administered by intravenous (IV) infusion

BIOLOGICAL

10-1074

Administered by intravenous (IV) infusion

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Roger Shapiro, MD, MPH · Harvard School of Public Health (HSPH)

  • Daniel Kuritzkes, MD · Brigham and Women's Hospital

  • Mathias Lichterfeld, MD, PhD · Brigham and Women's Hospital/Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
96 Weeks
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2021-12-03
Completion
2021-12-03
FDA Drug
Yes

Countries

  • Botswana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03707977 on ClinicalTrials.gov