Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07030920

Reducing Systemic Inflammation in People on Antiretroviral Therapy to Lower Cardiovascular Risk

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-11-19

150

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding fostemsavir to the current antiretroviral therapy can reduce the risk of cardiovascular disease in people living with HIV who have well-controlled infection. This Phase IIb randomized, open-label clinical trial focuses on individuals with undetectable viral loads but detectable soluble HIV gp120, which is linked to chronic inflammation and increased health risks such as cardiovascular disease, cognitive decline, and frailty. Participants will be randomly assigned to one of two groups: one group will take fostemsavir (Rukobia 600 mg extended-release tablet) once daily along with their existing antiretroviral regimen for 24 months, while the other group will continue their standard care with current antiretroviral therapy and other prescribed medications. The study uses a 1:1 randomization process stratified by sex and statin use, with follow-up visits scheduled at months 1, 6, 12, 18, 24, and 27. Throughout the study, participants will undergo assessments including coronary computed tomography angiography (CCTA), grip strength tests, and cognitive testing (B-CAM) at baseline and at month 24. Blood samples will be collected at each visit for biomarker analysis. Researchers will monitor changes in uncalcified plaque volume, cardiovascular events, cognitive ability, and grip strength, as well as safety outcomes such as adverse events and treatment discontinuation. The total study duration for participants is about 27 months.

CONDITIONS

Brief Title

Reducing Systemic Inflammation in People on Antiretroviral Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 40 years or older, or have lived with HIV for 25 years or more, any sex
  • Undetectable HIV viral load (less than 50 copies/ml within the last 6 months)
  • At least one cardiovascular risk factor such as longstanding HIV infection, hypertension, diabetes, smoking, dyslipidemia, family history of early cardiovascular disease, or known previous cardiovascular disease
  • Past cardiovascular disease must be stable and events must have occurred at least 3 months before screening
  • Detectable plasmatic sgp120 levels within the past year
Not Eligible

You will not qualify if you...

  • Known allergy to fostemsavir
  • Current treatment with strong cytochrome P450 (CYP3A) inducers
  • Pregnant, planning pregnancy, or breastfeeding; females of childbearing potential must have negative pregnancy test at baseline and use contraception
  • Contraindication for CT scan including low kidney function or iodine allergy
  • High prior exposure to ionizing radiation outside clinical care
  • Uncorrected prolonged QT interval or long QT syndrome
  • Current or anticipated treatment with specific heart rhythm medications
  • Unstable liver disease or severe liver abnormalities
  • Inability to provide informed consent
  • Life expectancy less than 36 months
  • Unable to attend study visits
  • Participation in another interventional trial
  • Known congestive heart failure with NYHA class 3 or 4 symptoms

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 24 months

Participants are randomized to either add fostemsavir once daily to their current ART regimen for 24 months or continue with standard of care without additional treatment.

Visits at month 1, 6, 12, 18, and 24

Follow-up

Duration - 3 months

Participants are monitored for 3 months after treatment ends to assess clinical events and safety outcomes.

1 visit at month 27

Trial Site Locations

Total: 1 location

1

CR CHUM

Montreal, Quebec, Canada, H2X 0A9

Actively Recruiting

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Research Team

B

Branka Vulesevic, TRIAL MANAGER

M

Madeleine Durand, STUDY SPONSOR

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Plasma Human Immunodeficiency Virus 1 Soluble Glycoprotein 120 Association With Correlates of Immune Dysfunction and Inflammation in Antiretroviral Therapy-Treated Individuals With Undetectable Viremia.

Mehdi Benlarbi, Jonathan Richard, Catherine Bourassa...

https://pubmed.ncbi.nlm.nih.gov/38035854

Association between HIV infection, antiretroviral therapy, and risk of acute myocardial infarction: a cohort and nested case-control study using Québec's public health insurance database.

Madeleine Durand, Odile Sheehy, Jean-Guy Baril...

https://pubmed.ncbi.nlm.nih.gov/21499115

The Canadian HIV and aging cohort study - determinants of increased risk of cardio-vascular diseases in HIV-infected individuals: rationale and study protocol.

Madeleine Durand, Carl Chartrand-Lefebvre, Jean-Guy Baril...

https://pubmed.ncbi.nlm.nih.gov/28893184