← Back to Search

Monoclonal Antibodies

bNAbs + N-803 for HIV/AIDS

Phase 1

Waitlist Available

Led By Marina Caskey, MD

Research Sponsored by Rockefeller University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On antiretroviral therapy with plasma HIV-1 RNA levels of < 50 copies/ml and no reported interruption of ART for 7 consecutive days or longer for at least 48 weeks, and < 20 copies/ml at screening

Confirmed HIV-1 infection

Must not have

ART initiated during acute infection

History of or current clinical atherosclerotic cardiovascular disease (ASCVD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of two long-acting broadly neutralizing antibodies, plus an IL-15 superagonist complex, in treating adults with HIV who are already on antiretroviral therapy.

Who is the study for?

Adults aged 18-70 with confirmed HIV-1 infection, on effective antiretroviral therapy for at least 48 weeks, and with a stable immune status. Participants must not have had significant interruptions in their HIV treatment, no recent malignancies or hepatitis B/C infections, and agree to use contraception.

What is being tested?

The study is testing the combination of two long-acting antibodies (3BNC117-LS and 10-1074-LS) given intravenously once, plus an IL-15 superagonist complex (N-803) given subcutaneously every three weeks during a break from standard HIV treatments.

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms due to immune activation by N-803, allergic responses to the antibodies administered intravenously, and possible temporary increases in viral load.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on HIV treatment with undetectable virus levels for at least 48 weeks.

Select...

I am HIV positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I started antiretroviral therapy soon after my infection was diagnosed.

Select...

I have a history of heart disease related to artery blockage.

Select...

I have hepatitis B or C.

Select...

I have had cancer linked to HIV, like Kaposi's sarcoma or lymphoma.

Select...

My HIV is resistant to drugs in two or more classes.

Select...

I don't have any major health issues that would stop me from joining.

Select...

I have never had Progressive Multifocal Leukoencephalopathy (PML).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ART not restarted by weeks 60 and 72

ART not restarted when bNABs below threshold

Any serious adverse events

+3 more

Secondary study objectives

Anti-drug antibodies (ADA)

Changes in HIV-1 specific T Cell immune responses

Half-life of 3BNC117-LS and 10-1074-LS

+5 more

Other study objectives

HIV-1 specific T cell immune response changes

Latent HIV-1 reservoir composition

Neutralization sensitivity

+1 more

Side effects data

From 2022 Phase 1 trial • 6 Patients • NCT04250636

17%

Tinea capitis

17%

Penile trauma

17%

Seasonal allergy

17%

COVID-19

17%

Pyrosis

100%

80%

60%

40%

20%

Study treatment Arm

Study Participants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 3BNC117-LS + 10-1074-LS + N-803Experimental Treatment3 Interventions

3BNC117-LS dosed at 30 mg/kg IV, day 0 10-1074-LS dosed at 10 mg/kg IV, day 0 N-803 dosed at 6 mcg/kg, SC, 8 doses every 3 weeks (week 1 through week 22)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

3BNC117-LS

2020

Completed Phase 1

~130

10-1074-LS

2020

Completed Phase 1

~90