Triple Immune Regimen for HIV
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you must be on a specific HIV treatment regimen before joining. You cannot use complementary or alternative medicines within 14 days before starting the study.
What data supports the effectiveness of the Triple Immune Regimen for HIV treatment?
Is vesatolimod safe for humans?
What makes the Triple Immune Regimen for HIV unique compared to other HIV treatments?
The Triple Immune Regimen for HIV is unique because it combines multiple components, including ChAdOx1 and MVA vectors, which are designed to stimulate the immune system in a novel way, potentially offering a different mechanism of action compared to traditional antiretroviral therapies that primarily target viral replication.411121314
What is the purpose of this trial?
The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).
Research Team
Sharon Riddler, MD, MPH
Principal Investigator
University of Pittsburgh
Eligibility Criteria
Adults who started ART for acute HIV within 28 days of diagnosis, have been on consistent treatment without breaks longer than 14 days, and have maintained an undetectable viral load for at least a year. They must weigh between 50-115 kg, have a CD4 count ≥500 cells/mm3, and agree to use two forms of contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Study Intervention and ART
Participants receive the study intervention including ChAdOx1 and MVA/HIVconsvX vaccines, vesatolimod, and bnAbs while continuing ART
Analytic Treatment Interruption
Participants undergo a treatment interruption to evaluate HIV-1 control
ART Restart
Participants who experience virologic rebound resume ART
Continuation of ATI
Participants who do not meet ART restart criteria continue the treatment interruption
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ChAdOx1.HIVconsv62
- ChAdOx1.tHIVconsv1
- GS-2872
- GS-5423
- MVA.tHIVconsv3
- MVA.tHIVconsv4
- Placebo
- Vesatolimod (VES)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
University of Oxford
Collaborator