Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 through 5 years (260 weeks) after aav8-vrc07 product administration
Awards & highlights
VRC 603 Trial 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.Check my eligibility
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.See study design
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.
VRC 603 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I am in good health with no significant medical issues.
VRC 603 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Geometric Mean Concentration of VRC07 Serum Antibodies (PK ELISA)
Geometric Mean Endpoint Titer of Anti-AAV8 Antibodies
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of AAV8-VRC07 Product Administration
+7 moreSecondary outcome measures
Concentration of VRC07 Serum Antibodies (Singulex Assay)
Geometric Mean Value of CD4 Cell Counts
Viral Load
VRC 603 Trial Design
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)
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,690 Total Patients Enrolled
Joseph P Casazza, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an ongoing liver condition like chronic hepatitis.My high blood pressure is not controlled by medication.I am between 18 and 65 years old.I am in good health with no significant medical issues.I weigh more than 115 kg.I have received gene therapy before.I have been on a consistent HIV medication regimen for at least 3 months.I have received a monoclonal antibody treatment before.I am currently breastfeeding or planning to get pregnant during the study.I agree to use condoms for a year after getting the study treatment.I am a woman who will use birth control during the study and am not pregnant.I am currently infected with COVID-19.I am currently fighting an infection related to AIDS.I have a bleeding disorder or experience significant bruising or bleeding with injections or blood draws.I agree to give blood samples for indefinite research use.
Research Study Groups:
This trial has the following groups:- Group 1: Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM)
- Group 2: Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM)
- Group 3: Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must an individual meet to be eligible for participation in this clinical trial?
"This medical experiment is actively recruiting 10 willing and able participants between the age of 18 to 65 who are diagnosed with HIV. To be eligible, patients must have completed an informed consent process, been on a stable antiretroviral regimen for at least 3 months and show no evidence of clinically significant lab abnormalities or additional medical conditions based on history and examination."
Answered by AI
Does this research trial include individuals aged 25 and above?
"This trial only allows participants who are between 18 and 65 to join. If a patient is underage, they can look into the 5 clinical trials specifically designed for minors; seniors have 13 options available to them."
Answered by AI
Are there any vacancies remaining for participants of this experiment?
"According to the information provided on clinicaltrials.gov, this study is not currently enrolling participants; it was initially posted on November 1st 2018 and updated most recently on October 27th 2022. Nevertheless, 18 other trials are presently seeking patients at present."
Answered by AI
To what extent could VRC-HIVAAV070-00-GT (AAV8-VRC07) be hazardous to human health?
"Our assessment of the safety profile for VRC-HIVAAV070-00-GT (AAV8-VRC07) is a 1, as this phase 1 trial only has limited evidence to support its efficacy and safety."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger