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Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults

NCT02840474 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-01-30

Study results available
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Summary

Background:

The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated. In Part A of the study, the researchers studied VRC01LS. Part A of the study was completed in 2017. In Part B, the researchers studied VRC07-523LS. Depending on which antibody received, researchers studied the amount of VRC01LS or VRC07-523LS in the body and how it changes over time. They evaluated the effect of antibodies on CD4+ (Cluster of Differentiation 4) lymphocyte count and HIV viral load, and checked to see if people who get VRC01LS or VRC07-523LS develop an immune response to it.

Objective:

To see if VRC01LS and VRC07-523LS are safe and well tolerated.

Eligibility:

Adults ages 18-70 who are HIV infected but otherwise healthy.

Design:

Participants received the study drug one time by IV infusion. A needle guided a thin tube into a vein. The study drug mixed with salt water was dripped into the vein over about 30 minutes.

Participants were monitored for 30 minutes after the infusion.

Blood samples were taken at the following times:

* Once before the infusion
* 5 times in the 4 hours after the infusion
* 1 time 24 hours after infusion. Some participants may have had 3 optional blood draws in the time period between 4 and 24 hours.

For 3 days after the infusion, participants recorded their temperature and reactogenicity symptoms in a diary.

There were a total of 23 study visits over 48 weeks. Ten visits were in the first 4 weeks. At all visits, participants answered health questions and gave blood samples.

Conditions

Interventions

BIOLOGICAL

VRC-HIVMAB080-00-AB

VRC01LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1.

BIOLOGICAL

VRC-HIVMAB075-00-AB

VRC07-523LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1.

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

  • Martin R Gaudinski, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2020-01-15
Completion
2020-01-15
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

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 NCT02840474 on ClinicalTrials.gov