Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions

Summary

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.

Conditions

• HIV

Interventions

BIOLOGICAL

VRC-HIVMAB060-00-AB (VRC01)

VRC01 is a broadly neutralizing human mAb targeted against the HIV-1CD4 binding site. As single intravenous infusion of VRC01(40 mg/kg) plus10-1074 (30mg/kg) or placebo will be administered after the first analytical treatment interruption phase once the subject's plasma viremia is \> or = 200 copies/mL.

BIOLOGICAL

10-1074

10-1074 is a recombinant, fully human mAb of the IgG1 lambda isotype that specifically binds to the base of the V3 loop within HIV-1 envelope gp-120. A single intravenous infusion of VRC01 (40 mg/kg) plus 10-1074 (30 mg/kg) or placebo will be administered after the first analytical treatment interruption phase once the subject's plasma viremia is \> or = 200 copies/mL.

BIOLOGICAL

Normal Saline Placebo

2 sequential infusions of normal saline placebo in matching volumes to antibody infusions will be administered after the first analytical treatment interruption phase once the subject's plasma viremia is \> or = 200 copies/mL.

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

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-04

Primary Completion

2020-12-08

Completion

2020-12-08

FDA Drug

Yes

Countries

• United States

Study Locations