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Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy

NCT03208231 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-05-24

Study results available
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Summary

The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC01

40 mg/kg of VRC01 administered by subcutaneous injection.

DRUG

Combination Antiretroviral Therapy (cART)

All infants received non-study provided cART selected by their primary care provider and supplied through non-study sources (i.e., cART not provided through the study).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Elizabeth (Betsy) McFarland, MD · University of Colorado School of Medicine

  • Alka Khaitan, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2020-06-16
Completion
2021-02-11
FDA Drug
Yes

Countries

  • Botswana
  • Brazil
  • Malawi
  • 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 NCT03208231 on ClinicalTrials.gov