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VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption

NCT02471326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-10-31

Study results available
· View outcomes & findings →

Summary

Background:

\- A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very low for a long time. But cART can lose effectiveness and cause permanent side effects. If treatment stops, HIV levels go up again. Researchers want to see if a new product can control HIV levels when a person is off cART.

Objective:

\- To see if the new product VRC01 is safe and can control the HIV level in the blood when a person is not taking cART.

Eligibility:

\- Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24 weeks.

Design:

* Participants will be screened with:
* Physical exam
* Medical history
* Heart tests
* Blood and urine tests.
* Their HIV drugs may be switched. They will keep taking them until a few days after Visit 1.
* Visit 1: Repeat screening procedures.
* Participants will also have genetic testing and leukapheresis. For this, blood will be removed through a needle in one arm and circulated through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm.
* They will get the first study drug dose through a thin tube in an arm vein for about 1 hour.
* For 24 weeks, participants will have 16 visits. They will have blood drawn every visit. At some visits they will repeat the screening procedures and get another VRC01 dose. They may have another leukapheresis.
* Four weeks after the last dose, participants will restart their cART. For 20 weeks, they will have monthly visits to repeat the screening procedures and discuss new symptoms.

Conditions

Interventions

BIOLOGICAL

VRC-HIVMAB060-00-AB (VRC01)

A potent HIV-specific monoclonal antibody

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael C Sneller, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-07-13
Primary Completion
2017-04-07
Completion
2017-04-07
FDA Drug
Yes

Countries

  • United States

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 NCT02471326 on ClinicalTrials.gov