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

Recruiting in Palo Alto (17 mi)

Overseen byJoseph P Casazza, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Trial Summary

What is the purpose of this trial?Background: The Human Immunodeficiency Virus (HIV) attacks the immune system. Scientists have created a gene that could be transferred to the cells of people with HIV. The gene should tell the cells to make an antibody called VRC07. This antibody fights HIV. The VRC07 gene is packaged into a man-made version of a virus called AAV8. Objectives: To see if AAV8-VRC07 is safe. To study if it causes cells to produce the VRC07 antibody. Eligibility: Adults ages 18-65 who are HIV infected but in general good health and have been taking the same HIV medicine for at least 3 months Design: Participants were screened in a different protocol. Participants received the study product on day 1. It was injected one or more times in the upper arm or thigh using a needle. Participants weight was measured to calculate the dose. Women may have had a pregnancy test. For 7 days after getting the study product, participants checked their temperature with a thermometer. They noted any symptoms in an electronic or paper diary. Participants will have study visits. At each one, they will have a physical exam and medical history. They will have blood drawn and may have saliva collected. The study visit schedule is as follows: For 12 weeks: 1 visit a week For the next 12 weeks: 1 visit every other week Then about 1 visit a month After 1 year in the study: a visit every 6 months for the next 4 years. Total study participation is 5 years.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 65 years old.

I am in good health with no significant medical issues.

Willing to maintain or establish a relationship with a primary health care provider for medical management of HIV infection while participating in the study

+9 more

Exclusion Criteria

I have an ongoing liver condition like chronic hepatitis.

My high blood pressure is not controlled by medication.

I weigh more than 115 kg.

+11 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Group I: Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM)Experimental Treatment1 Intervention

AAV8-VRC07 (2.5 x 10\^12 vg/kg) administered by IM injection (Day 0)

Group II: Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM)Experimental Treatment1 Intervention

AAV8-VRC07 (5 x 10\^11 vg/kg) administered by IM injection (Day 0)

Group III: Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM)Experimental Treatment1 Intervention

AAV8-VRC07 (5 x 10\^10 vg/kg) administered by intramuscular (IM) injection (Day 0)