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Monoclonal Antibodies

AAV8-Delivered Antibody for HIV Infection (VRC 603 Trial)

Phase 1

Waitlist Available

Led By Joseph P Casazza, M.D.

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

Aged between 18 to 65 years

Must be in general good health with no evidence of clinically significant lab abnormalities and without additional clinically significant medical conditions as per exclusion criteria

Must not have

Active liver disease such as chronic hepatitis

Hypertension that is not well controlled by medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 through 5 years (260 weeks) after aav8-vrc07 product administration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a gene that could be transferred to the cells of people with HIV, in order to make them produce an antibody called VRC07, which fights HIV. The gene is packaged into a man-made version of a virus called AAV8. The trial is testing to see if AAV8-VRC07 is safe and if it causes cells to produce the VRC07 antibody.

Who is the study for?

Adults aged 18-65 living with HIV, in good health, on stable HIV medication for at least 3 months. Participants must agree to use contraception and not be pregnant or breastfeeding. Excludes those with previous monoclonal antibody treatment, certain pre-existing antibodies, heavy weight (for Group 3), uncontrolled hypertension, active liver disease or severe allergies.

What is being tested?

The trial tests AAV8-VRC07's safety and its ability to make cells produce the VRC07 antibody against HIV. It involves a gene packaged into a man-made virus injected into participants' arms or thighs. The study spans over five years with regular visits for physical exams and sample collections.

What are the potential side effects?

Potential side effects are not detailed but may include reactions at the injection site, immune responses due to the introduction of new genetic material via viral vector (AAV8), and any unforeseen effects from long-term production of the VRC07 antibody.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I am in good health with no significant medical issues.

Exclusion Criteria

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

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I have an ongoing liver condition like chronic hepatitis.

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My high blood pressure is not controlled by medication.

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I have received gene therapy before.

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I have received a monoclonal antibody treatment before.

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I am currently breastfeeding or planning to get pregnant during the study.

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I am currently infected with COVID-19.

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I am currently fighting an infection related to AIDS.

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I have a bleeding disorder or experience significant bruising or bleeding with injections or blood draws.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 through 5 years (260 weeks) after aav8-vrc07 product administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 through 5 years (260 weeks) after aav8-vrc07 product administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through 5 years (260 weeks) after aav8-vrc07 product administration for reporting.