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Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults

NCT02165267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-10-15

No results posted yet for this study

Summary

Antibodies are natural proteins that the body makes to fight infections. Antibodies can also be manufactured like a drug and infused or injected into the body to prevent or treat a disease. The purpose of this study is to test the safety of and the body's response to an antibody against HIV in healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC01

Administered IV in 100 mL of normal saline (Sodium Chloride for Injection 0.9%, USP) or administered SC by needle and syringe injection.

BIOLOGICAL

SC placebo for VRC01

Sterile, buffered aqueous solution of 25 mM Sodium Citrate, 50 mM Sodium Chloride, 150 mM L-Arginine Hydrochloride, 10% Dextran 40, and 0.005% Polysorbate 80 at pH 5.8 administered SC by needle and syringe injection

BIOLOGICAL

IV placebo for VRC01

Sodium Chloride for Injection 0.9%, USP administered IV in 100 mL of normal saline (Sodium Chloride for Injection 0.9%, USP)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kenneth Mayer · The Fenway Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

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 NCT02165267 on ClinicalTrials.gov