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Virus Therapy

VIR-1111 for HIV

Phase 1
Waitlist Available
Research Sponsored by Vir Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through 36 weeks
Awards & highlights

Study Summary

This trial is testing a new drug, VIR-1111, to see if it is safe and effective in preventing HIV infection. The trial is open to healthy adults who are at low risk for HIV infection and have CMV. Participants will be given either VIR-1111 or a placebo, and will be monitored for safety, side effects, and how well the drug works. There is an optional follow-up study that would lengthen study participation for up to 3 years post-first dose.

Eligible Conditions
  • HIV

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with CMV vector shedding (urine and saliva)
Number of participants with CMV vector viremia (blood)
Number of participants with any local site reactogenicity event after first dose
+6 more
Secondary outcome measures
Binding titers of CMV-specific IgG antibodies
Binding titers of HIV Clade A Gag-specific IgG antibodies
Frequency of CMV-specific CD4 T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect IL-2 AND/OR IFNg AND/OR CD154
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VIR-1111Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIR-1111
2020
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vir Biotechnology, Inc.Lead Sponsor
27 Previous Clinical Trials
13,231 Total Patients Enrolled
Bill and Melinda Gates FoundationOTHER
407 Previous Clinical Trials
22,924,061 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities available for participants to join this research endeavor?

"According to the clinicaltrials.gov data, this research endeavour is not currently recruiting participants as of now but was first published on December 28th 2020 and had a recent edit on July 22nd 2022. Despite that, there are still 576 other medical studies actively accepting patients at present."

Answered by AI

What potential risks are associated with VIR-1111?

"The safety of VIR-1111 is only partially understood, and so a score of 1 was assigned to it. This indicates that there is minimal data available in support of its efficacy and safety profile."

Answered by AI

In what geographic locations is this clinical research taking place?

"The current enrolment pool is open in 4 sites, including Madison, Miami and Boston. To limit the amount of travel needed if accepted into the study, it's beneficial to choose a location that's closest to you."

Answered by AI

Could I be a participant in this trial?

"This clinical trial is readying to accept 26 individuals suffering from Human Immunodeficiency Virus type 1 (HIV-1) and aged between 18 and 50. To qualify, participants must have a positive CMV serostatus, be deemed low risk for HIV infection by the clinic staff, agree to donate bodily fluids as required by the protocol, present no major health issues based on medical history or laboratory tests, not be of childbearing potential, use condoms throughout their participation in the study period up to Week 36 or until its conclusion date. Moreover they will need to go through an HIV test with counseling and receive results afterwards."

Answered by AI

Is candidacy for the clinical trial restricted to individuals 45 years or younger?

"This specific medical study is limited to those aged 18-50. However, it appears that there are 124 trials available for minors and 425 clinical studies open to seniors above the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
2020. "VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725877.
~6 spots leftby Apr 2025
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