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Cytokine

IL-15 Superagonist + Antibodies for HIV/AIDS

Phase 1

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

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

Must have

HIV-1 infection

On ART regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization

Must not have

Receipt of any therapeutic HIV vaccine or monoclonal antibody therapy (anti-HIV or otherwise) at any time in the past

History of or current clinical cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, N-803, to see if it can help control HIV-1 without the need for antiretroviral therapy.

Who is the study for?

This trial is for adults with HIV/AIDS who've been on ART including an integrase inhibitor and NRTIs or dolutegravir/lamivudine for at least 96 weeks, have a stable CD4 count, no history of AIDS-defining illness except recurrent pneumonia, and agree to use contraception. They must not be pregnant, breastfeeding, or have used immunomodulatory meds recently.

What is being tested?

The study tests the safety and effectiveness of N-803 (an IL-15 superagonist) alone or combined with bNAbs (VRC07-523LS & 10-1074) in controlling HIV without regular treatment. Participants will temporarily stop their usual ART to see if these new drugs can maintain low HIV levels.

What are the potential side effects?

Potential side effects may include reactions related to immune activation such as fever or fatigue due to the IL-15 superagonist's action on the body's natural defenses. The broadly neutralizing antibodies might cause infusion-related reactions like mild discomfort or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I am infected with HIV-1.

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I have been on an ART regimen with specific drugs for at least 6 weeks.

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I have been on antiretroviral therapy for at least 96 weeks.

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My weight is between 50 kg and 115 kg.

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My HIV viral load has been under 50 copies/mL for the last 96 weeks.

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I have completed a leukapheresis procedure before joining.

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My lab results meet specific criteria for a study on my condition.

Exclusion Criteria

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

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I have never received an HIV vaccine or monoclonal antibody therapy.

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I have a history of heart disease.

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I am currently on HIV treatment that is not NRTI or integrase inhibitor.

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I started HIV treatment soon after my diagnosis.

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I haven't taken any immune system modifying drugs in the last 6 months.

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I have had cognitive issues due to HIV.

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I have had cancer linked to HIV.

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My HIV treatment has failed for at least two drug classes.

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I have received immunoglobulin therapy before.

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I have a serious ongoing health issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46

This trial's timeline: 3 weeks for screening, Varies for treatment, and at step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of N-803 doses completed

Proportion of participants requiring dose reduction

Secondary study objectives

Proportion of participants with antidrug antibodies

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: N-803 in combination with 10-1074 and VRC07-523LSExperimental Treatment3 Interventions

Participants will receive N-803 in combination with 10-1074 and VRC07-523LS as follows: * At Step 2 entry: * VRC07-523LS 20 mg/kg * 10-1074 30 mg/kg * At Step 2, week 1: N-803 6 mcg/kg every 3 weeks for eight doses * At Step 2, week 9: 10-1074 30 mg/kg

Group II: Arm A: N-803 onlyExperimental Treatment1 Intervention

Participants will receive N-803 6 mcg/kg 1 week after Step 2 entry and then every 3 weeks for a total of eight doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VRC07-523LS

2019

Completed Phase 2

~390

10-1074

2019