VRC-HIVMAB060-00-AB

Background:
A daily drug combination can keep human immunodeficiency virus (HIV) levels low for a long time. But if this combination antiretroviral therapy (ART) stops, HIV levels go back up. People can also develop resistance or permanent side effects. Researchers want to see if 2 new drugs can help control HIV when a person is not on ART.
Objective:
To see if VRC01 and 10-1074 are safe and control HIV when a person is not on ART.
Eligibility:
Adults 18-65 with HIV
Design:
All participants must agree to practice safer sex. Those who can get pregnant will have a pregnancy test every visit.
Participants will be screened with:
Physical exam
Medicine review
Blood and urine tests
Some participants may need to change their HIV medicine for a brief period of time during the study.
A few weeks later, participants will repeat screening tests and stop taking their HIV medicines.
Interruption phase 1: Participants will have blood tests every 2 weeks, and repeat screening tests every 4 weeks.
Treatment phase: Once their HIV reaches a certain level in the blood, participants will get the 2 study drugs or a salt water placebo. They will not know which they get. Each substance will be given through a thin tube in an arm vein for about 1 hour. Participants will restart their HIV medicines and repeat screening tests every 4 weeks.
Interruption phase 2: Once the level of HIV in the blood becomes undetectable for 3 months, participants will again stop taking their HIV medicines and have blood tests every 2 weeks to monitor the level of HIV in the blood.
Participants will restart their medicines by week 24. They will start sooner if they have certain symptoms or blood levels of HIV become too high. They will repeat most screening tests 3 times over 24 weeks.