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

Completed · Phase 1

Conditions studied: HIV

In brief

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.

Key facts

Study ID
NCT02471326
Run by
National Institute of Allergy and Infectious Diseases (NIAID)
People needed
10
Starts
2015-07-13
Expected to finish
2017-04-07
Last updated by the study team
2017-10-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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