VRC 603: A Phase I Dose-Escalation Study of the Safety of AAV8-VRC07 (VRC-HIVAAV070-00-GT) Recombinant AAV Vector Expressing VRC07 HIV-1 Neutralizing Antibody in Antiretroviral -Treated, HIV-1 Infected Adults With Controlled Viremia.

• Status: Recruiting
• Trial end date: 2027-03-01

Summary

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 - 60 who are HIV infected but in general good health and have been taking the same HIV medicine for at least 3 months

Design:

Participants will be screened in a different protocol.

Participants will get the study product on Day 0. It will be injected one or more times in the upper arm or thigh using a needle. Participants weight will be measured to calculate the dose.

Women may have a pregnancy test.

For 7 days after getting the study product, participants will check their temperature with a thermometer. They will note 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 visit schedule will be:

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.

• Phase: Phase 1

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents; Antibodies; Antibodies, Blocking; Immunoglobulins