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Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

NCT02256631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-02-08

Study results available
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Summary

The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC01

Administered by subcutaneous injection in the thigh

BIOLOGICAL

VRC01LS

Administered by subcutaneous injection in the thigh

BIOLOGICAL

VRC07-523LS

Administered by subcutaneous injection in the thigh

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Coleen Cunningham, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2020-06-17
Completion
2021-12-16

Countries

  • United States
  • Puerto Rico
  • South Africa
  • Zimbabwe

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 NCT02256631 on ClinicalTrials.gov