Recruiting

Phase 2

FostemsavirReducing Systemic Inflammation in People on Antiretroviral Therapy

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT07030920

Conditions

Human Immunodeficiency Virus (HIV)

Cardiovascular Risk Factor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fostemsavir

Study Details

Brief summary:

This randomized, open-label clinical trial will evaluate whether adding fostemsavir to current antiretroviral therapy can reduce the risk of cardiovascular disease in people with well-controlled HIV. Researchers will compare imaging, clinical and biomarker outcomes between participants who receive fostemsavir in addition to their existing treatment and those who continue with standard care alone.

Conditions

Human Immunodeficiency Virus (HIV)

Cardiovascular Risk Factor

Study ID

NCT07030920

Start date

Sep 30, 2025

Status verified date

Nov, 2025

Completion date

Jan, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

40 years or older, or have lived with HIV for 25 years or more, any sex;
Undetectable HIV viral load (defined as last viral load measurement less than 50 copies/ml within the last 6 months);
Presence of at least one cardiovascular risk factor among the following: longstanding HIV infection (25 years or more), hypertension, diabetes, past or present smoking, dyslipidemia, family history of early onset CVD in a first-degree relative (defined as younger than 55 in males or younger than 65 in females (80)), known previous cardiovascular disease (defined as past myocardial infarction, coronary revascularization, stroke, or coronary artery atherosclerosis with >= 50% stenosis demonstrated on coronary angiography or CCTA);
Participants with past cardiovascular disease must be in a stable clinical condition as judged by the study clinicians;
Past cardiovascular events are defined as having occurred at least 3 months before screening;
Evidence of detectable plasmatic sgp120 levels at any point in the past year, using the assay described priorly and performed at CRCHUM in Dr Andrés Finzi's laboratory.

Exclusion Criteria:

Known allergy to study drug;
Concomitant treatment with strong cytochrome P450 (CYP3A) inducers, including but not limited to: carbamazepine, phenytoin (anticonvulsants), mitotane (antineoplastic), enzalutamide (androgen receptor inhibitor), rifampicin (antimycobacterial) and St John's wort (Hypericum perforatum, herbal supplement);
Planning to become pregnant, pregnant, or breastfeeding (as requested per product monography (55)). Females of childbearing potential must have a negative pregnancy test at baseline visit, and follow contraception requirements throughout the treatment;
Contraindication for CT scan use (estimated glomerular filtration rate \[eGFR\] less than 40ml/min using the Modification of Diet in Renal Diseases \[MDRD\] formula or iodine allergy);
Elevated risk of prior ionizing radiation exposure outside clinical care exceeding 10 mSV over 3 years, per the investigator's judgement (eg. a participant with occupational ionizing radiation exposure, prior participation in clinical trials with multiple CT scans)
Confirmed uncorrected QT value >500ms or confirmed QTcF >470 msec for women and >450 msec for men;
Acquired/ congenital long QT syndrome;
Current or anticipated treatment with any of the following medications: amiodarone, disopyramide, dofetilide, ibutilide, procainamide, sotalol, and quinidine;
Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy (INR > 2.0), hypoalbuminemia (<30 mg/ml), untreated esophageal or gastric varices, or persistently elevated bilirubinemia (>1.5x upper limit of normal \[ULN\]), known biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment);
ALT >=5 times the ULN, OR ALT >=3xULN and bilirubin >=1.5xULN with >35% direct bilirubin;
History of liver cirrhosis with CHILD-PUGH classification C;
Inability to provide informed consent;
Life expectancy of less than 36 months;
Inability to present to study visits;
Participation in another interventional trial;
Known Congestive heart failure with NYHA class 3 or 4.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rukobia 600 mg daily

no intervention: Standard of care (SOC)

Participants will continue to follow their current ART regimen, as well as other medications prescribed by their treating physician throughout the trial

Interventions

Fostemsavir

Addition of fostemsavir to the patient's current antiretroviral regimen: once daily oral administration (Rukobia 600 mg extended-release tablets) for 24 months

Primary outcome measure

Change in total uncalcified plaque volume between baseline and month 24 [ Time Frame: From baseline to end of treatment (+ 24 months) ]

Central Contacts and Locations

Central contacts

Branka Vulesevic, TRIAL MANAGER

15148908000 branka.vulesevic.chum@ssss.gouv.qc.ca

Madeleine Durand, STUDY SPONSOR

madeleine.durand@umontreal.ca

Locations

CR CHUM

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Pascale Arlotto, STUDY NURSE

438-883-8933 pascale.arlotto.chum@ssss.gouv.qc.ca

Madeleine Durand, SITE DOCTOR, MD

RESTART.chum@ssss.gouv.qc.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

Fostemsavir
Rukobia
sgp120
Perivascular fat attenuation index (P-FAI)
uncalcified plaque volume
Systemic inflammation
Cardiovascular Risk Factor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-11-19.