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Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)

NCT02411539 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-11-05

Study results available
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Summary

The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC01

40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

BIOLOGICAL

Placebo

Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Sponsors & Collaborators

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sharon Riddler, MD, MPH · Pitt CRS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-25
Primary Completion
2016-04-15
Completion
2016-09-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02411539 on ClinicalTrials.gov