45 Participants Needed

Triple Immune Regimen for HIV

Recruiting at 13 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Integrase inhibitors, NRTIs

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?

The research on enfuvirtide, a drug used in combination with other antiretrovirals, shows that it can significantly increase CD4+ cell counts and reduce HIV RNA levels, suggesting potential benefits for immune system improvement in HIV patients.12345

Is vesatolimod safe for humans?

Vesatolimod has been tested in humans and is generally considered safe, as it was evaluated in a Phase Ib study for people living with HIV-1, showing immune activation without significant safety concerns.678910

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

SR

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

You must provide laboratory results taken within the past two months.
I have my HLA typing results available.
I have taken a pregnancy test within the last 48 hours and it was negative.
See 11 more

Exclusion Criteria

You have received an experimental vaccine or HIV-1 vaccine within the past 6 months.
You have known allergies or sensitivities to any of the ingredients used in the study treatments.
You have experienced a severe allergic reaction called anaphylaxis, which includes symptoms like hives, trouble breathing, or swelling.
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Study Intervention and ART

Participants receive the study intervention including ChAdOx1 and MVA/HIVconsvX vaccines, vesatolimod, and bnAbs while continuing ART

67 weeks

Analytic Treatment Interruption

Participants undergo a treatment interruption to evaluate HIV-1 control

up to 24 weeks

ART Restart

Participants who experience virologic rebound resume ART

24 weeks

Continuation of ATI

Participants who do not meet ART restart criteria continue the treatment interruption

up to 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ChAdOx1.HIVconsv62
  • ChAdOx1.tHIVconsv1
  • GS-2872
  • GS-5423
  • MVA.tHIVconsv3
  • MVA.tHIVconsv4
  • Placebo
  • Vesatolimod (VES)
Trial Overview The trial is testing the effectiveness of therapeutic vaccines using ChAdV and MVA vectors along with TLR7 agonist vesatolimod (VES) and bNAbs versus placebo in controlling HIV during treatment interruption. Participants will be monitored to see how well their bodies control HIV without regular medication.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Active ChAdOx1 and MVA/HIVconsvX vaccines, vesatolimod and bnAbsExperimental Treatment7 Interventions
Group II: Arm B: Placebos for vaccines, vesatolimod and bnAbsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Gilead Sciences

Industry Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

University of Oxford

Collaborator

Trials
1,113
Recruited
21,220,000+

Findings from Research

In a study of 187 HIV-infected patients over an average of 19.4 months, enfuvirtide treatment led to a significant mean increase of approximately 102 CD4+ cells/mm³, regardless of the patients' initial CD4+ cell counts.
Patients starting enfuvirtide with CD4+ counts below 100 cells/mm³ did not reach the same CD4+ levels as those starting with higher counts, suggesting that initiating treatment at higher CD4+ levels may provide better immunologic benefits, even if complete viral suppression is not achieved.
Immunologic benefits of enfuvirtide in patients enrolled in a drug assistance program.Saberi, P., Caswell, NH., Gruta, CI., et al.[2018]
In a review of 15 randomized controlled trials involving 3,497 patients, the combination of DRV/r and INSTIs was found to be more effective than triple therapy in achieving viral suppression and improving CD4+ T cell counts.
The safety profile of DRV/r + INSTIs was comparable to that of triple therapy, indicating that this dual therapy is not only effective but also safe for treatment-naïve HIV/AIDS patients.
Effectiveness and Safety Analysis of PIs/r Based Dual Therapy in Treatment-Naïve, HIV/AIDS Patients: A Network Meta Analysis of Randomized Controlled Trials.Hui, L., Xiaoxu, H., Yuqi, W., et al.[2022]
In a study of 89 very immunosuppressed HIV-1-infected patients, an efavirenz-based regimen showed similar effectiveness in increasing CD4 cell counts after 48 weeks compared to two ritonavir-boosted protease inhibitor regimens.
All three treatment regimens achieved comparable rates of viral suppression and had similar safety profiles, with no reported deaths, indicating that efavirenz can be a viable option for very advanced HIV-1 infection.
Immune Reconstitution in Severely Immunosuppressed Antiretroviral-Naive HIV-1-Infected Patients Starting Efavirenz, Lopinavir-Ritonavir, or Atazanavir-Ritonavir Plus Tenofovir/Emtricitabine: Final 48-Week Results (The Advanz-3 Trial).Miro, JM., Manzardo, C., Ferrer, E., et al.[2020]

References

Immunologic benefits of enfuvirtide in patients enrolled in a drug assistance program. [2018]
Effectiveness and Safety Analysis of PIs/r Based Dual Therapy in Treatment-Naïve, HIV/AIDS Patients: A Network Meta Analysis of Randomized Controlled Trials. [2022]
Immune Reconstitution in Severely Immunosuppressed Antiretroviral-Naive HIV-1-Infected Patients Starting Efavirenz, Lopinavir-Ritonavir, or Atazanavir-Ritonavir Plus Tenofovir/Emtricitabine: Final 48-Week Results (The Advanz-3 Trial). [2020]
AIDS therapy with two, three or four agent combinations, applied in short sequences, differing from each other by drug rotation. I. First of two parts: a phase I trial equivalent, concerning five virostatics: AZT, ddI, ddC, acriflavine and an ellipticine analogue. [2013]
[Therapeutic indications, antiretroviral treatment optimization and quality of life of patients taking enfuvirtide]. [2018]
Activation of HIV-specific CD8+ T-cells from HIV+ donors by vesatolimod. [2021]
The TLR7 agonist vesatolimod induced a modest delay in viral rebound in HIV controllers after cessation of antiretroviral therapy. [2022]
Vesatolimod, a Toll-like Receptor 7 Agonist, Induces Immune Activation in Virally Suppressed Adults Living With Human Immunodeficiency Virus-1. [2021]
Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. [2018]
Lopinavir/ritonavir vs. indinavir/ritonavir in antiretroviral naive HIV-infected patients: immunovirological outcome and side effects. [2013]
Highly active antiretroviral therapy including protease inhibitors does not confer a unique CD4 cell benefit. The AVANTI and INCAS Study Groups. [2004]
Genotypic and phenotypic characterization of HIV-1 isolated from patients receiving (--)-2',3'-dideoxy-3'-thiacytidine. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Clinical impact of the M184V mutation on switching to didanosine or maintaining lamivudine treatment in nucleoside reverse-transcriptase inhibitor-experienced patients. [2022]
Evolving simplified treatment strategies for HIV infection: the role of a single-class quadruple-nucleoside/nucleotide regimen of trizivir and tenofovir. [2022]
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