Human Immunodeficiency Virus (HIV)Phase 2RESTARTNCT07030920
Reducing Systemic Inflammation in People on Antiretroviral Therapy
A Phase 2 study testing Fostemsavir in people with Human Immunodeficiency Virus (HIV) and Cardiovascular Risk Factor, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Cardiovascular Risk Factor
- What is being tested?
- Fostemsavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2025to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Madeleine Durand, STUDY SPONSOR contact
Canada1 site, 1 recruiting
- Recruiting
CR CHUM
Montreal, Quebec, H2X 0A9
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
About this study
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.
Read the detailed description
A randomized, controlled trial of fostemsavir versus standard of care to curb comorbidity in people with well-controlled HIV. (Phase IIb study)
Background and hypothesis: People living with HIV, even when treated with antiretrovirals, develop early onset comorbidities such as cardiovascular disease, cognitive decline and frailty. In a subset of those, this could be due to residual viral particles driving chronic inflammation. Soluble glycoprotein 120 (sgp120) is detectable in close to a third of people living with HIV with undetectable HIV plasma viral loads. It is associated to increased inflammation and immune dysfunction.
People living with HIV with undetectable viral load but detectable soluble HIV gp120 (sgp120) are exposed to chronic inflammation, sustained immune dysfunction, and increased risk of comorbidity. The investigators hypothesize that the addition of fostemsavir, which has been shown to prevents the binding of sgp120 to the human CD4 receptor, to reduce cytokine burst and antibody-dependant cellular citotoxicity, decreased inflammation and immune dysfunction, leading to improved health.
Study population: People living with HIV on antiretroviral therapy, with undetectable viral load and detectable plasmatic sgp120.
Study intervention: The intervention will be either the addition of fostemsavir (Rukobia 600 mg daily) for 24 months to the patient's current ART regimen, or standard of care, which includes the continuation of the ARV regimen and other medications prescribed by their physicians.
Randomization: This is a randomized, open label study with blind outcome adjudication. Randomization will be done in a 1:1 ratio with allocation in parallel arms, stratified by sex and participant statin use at recruitment, through a computerized algorithm with permuted blocks of randomly varying size, to ensure allocation concealment.
Treatment groups:
Arm 1 (active):
- Once daily oral administration (600 mg extended-release tablet) for 24 months Arm 2 (Standard of care)
- Participants will continue to follow their current ART regimen, as well as other medications prescribed by their treating physician throughout the trial
Study procedures: At baseline, participants will undergo a CCTA, grip strenght, a B-CAM (online cognitive testing) and contribute blood to the study biobank. Participants will be randomized during the baseline visit, and those randomized to fostemsavir will start taking study treatment. Visits will be done at month 1, 6, 12, 18, 24 and 27. The duration of treatment will be 24 months. At month 24, the CCTA, grip strenght and cognition measures will be repeated. Participants will contribute to the biobank at each study visit.
Study outcomes:
Primary Outcome: Change in total uncalcified plaque volume between baseline and month 24, contrasted between fostemsavir and standard of care.
Imaging Secondary Outcome: Perivascular fat attenuation index at month 24, adjusted for baseline values.
Clinical Secondary Outcome: Clinical events - time to major adverse cardiovascular event, B-CAM (cognition testing) and grip strength at month 24 (adjusted for baseline values).
Biomarker Secondary Outcomes: Biomarkers identified in biobanking samples (virology, immunology, inflammation).
Safety Secondary Outcomes: Risk of adverse events and incidence of treatment discontinuation due to side effects.
A biomarker interim analysis will be performed when 50% of the planned samples size will have completed 1 year of follow-up. Pre-specified biomarker outcomes will be measured using the study-associated biobank.
The intervention will be either the addition of fostemsavir (Rukobia 600 mg daily) to the patient's current ART regimen, or the participant receiving the standard of care.
Statistical considerations:
The planned sample size is 150 (approxiimately 75 per arrm. ) Statistical analysis will be conducted by CITADEL (CRCHUM) after the closing of the study database, according to the statistical analysis plan, which will be registered before the analysis is conducted. All analyses will be done by intention-to-treat; patients will be analyzed in the group they were randomized to. Biobank analyses planned after 50% of participants completed the 12 months biobanking will be done by CITADEL after this part of the data collection is closed.
- Being tested
- Fostemsavir
- Keywords
- Fostemsavir, Rukobia, sgp120, Perivascular fat attenuation index (P-FAI), uncalcified plaque volume, Systemic inflammation, Cardiovascular Risk Factor
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostemsavirDrug
Addition of fostemsavir to the patient's current antiretroviral regimen: once daily oral administration (Rukobia 600 mg extended-release tablets) for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Rukobia 600 mg daily | Experimental | Not described Receives: Drug: Fostemsavir |
| Standard of care (SOC) | No intervention | Participants will continue to follow their current ART regimen, as well as other medications prescribed by their treating physician throughout the trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total uncalcified plaque volume between baseline and month 24
The change in total uncalcified plaque volume between baseline and month 24 will be measured by coronary compted tomography angiography and contrasted between fostemsavir and standard of care
Measured: From baseline to end of treatment (+ 24 months)
Secondary outcomes (5)
Imaging outcome: Perivascular fat attenuation index at month 24, adjusted for baseline values
The perivascular fat attenuation index at month 24, adjusted for baseline values, will be measured by CCTA and contrasted between fostemsavir and standard of care
Measured: From baseline to end of treatment (+ 24 months)
Time to Major Adverse cardiovascular Event (MACE)
The time to MACE will be recorded throughout the study. MACEs are defined as myocardial infarction, coronary revascularization by percutaneous coronary intervention or surgery, peripheral artery revascularization, stroke, hospitalization for heart failure or unstable angina, or cardiovascular death
Measured: From baseline to post-treatment visit (+ 27 months)
Risk of severe and serious adverse events
Measured: From baseline to post-treatment visit (+ 27 months)
Grip strength at 24 months, adjusted for baseline
Grip strength, a marker of sarcopenia, will be measured at month 24, adjusted for baseline. Grip strength will be measured using the standard operating procedures common to the Canadian HIV and Aging Cohort Study (CHACS) and Women's Interagency HIV Study (WHIS).
Measured: From baseline to end of treatment (+ 24 months)
Brief Cognitive Ability Measure (B-CAM) scores at month 24, adjusted for baseline
B-CAM scores will be measured at month 24, adjusted for baseline. B-CAM scores will be measured using a web-based measurement tool that has been developed for cognitive assessment in PWH. It can be administered in less than 30 minutes, has been shown to be superior to the Montreal Cognitive Assessment Score (MoCA) to assess cognition in PWH, and remains valid when used repetitively in the same individual, with no need to adjust for practice effects.
Measured: From baseline to end of treatment (+ 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start30 Sep 2025
- Primary completionOct 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be done in a 1:1 ratio, with allocation in parallel arms, stratified by sex and participant statin use at recruitment, through a computerized algorithm with permuted blocks of randomly varying size, to ensure allocation concealment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Clinique du Quartier Latin, BC Women's Hospital & Health Centre
- Responsible party
- Sponsor
- Investigators
- Madeleine Durand, MD MSc FRCPC, Principal investigator, CR CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030920
- Sponsor's protocol ID
- MP-02-2025-12725
- Other IDs
- II2-195573
- Acronym
- RESTART
- Status last verified
- Nov 2025
- First submitted
- 5 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benlarbi M, Richard J, Bourassa C, Tolbert WD, Chartrand-Lefebvre C, Gendron-Lepage G, Sylla M, El-Far M, Messier-Peet M, Guertin C, Turcotte I, Fromentin R, Verly MM, Prevost J, Clark A, Mothes W, Kaufmann DE, Maldarelli F, Chomont N, Begin P, Tremblay C, Baril JG, Trottier B, Trottier S, Duerr R, Pazgier M, Durand M, Finzi A. Plasma Human Immunodeficiency Virus 1 Soluble Glycoprotein 120 Association With Correlates of Immune Dysfunction and Inflammation in Antiretroviral Therapy-Treated Individuals With Undetectable Viremia. J Infect Dis. 2024 Mar 14;229(3):763-774. doi: 10.1093/infdis/jiad503.
PubMed 38035854Richard J, Prevost J, Bourassa C, Brassard N, Boutin M, Benlarbi M, Goyette G, Medjahed H, Gendron-Lepage G, Gaudette F, Chen HC, Tolbert WD, Smith AB 3rd, Pazgier M, Dube M, Clark A, Mothes W, Kaufmann DE, Finzi A. Temsavir blocks the immunomodulatory activities of HIV-1 soluble gp120. Cell Chem Biol. 2023 May 18;30(5):540-552.e6. doi: 10.1016/j.chembiol.2023.03.003. Epub 2023 Mar 22.
PubMed 36958337Durand M, Sheehy O, Baril JG, Lelorier J, Tremblay CL. Association between HIV infection, antiretroviral therapy, and risk of acute myocardial infarction: a cohort and nested case-control study using Quebec's public health insurance database. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):245-53. doi: 10.1097/QAI.0b013e31821d33a5.
PubMed 21499115Durand M, Chartrand-Lefebvre C, Baril JG, Trottier S, Trottier B, Harris M, Walmsley S, Conway B, Wong A, Routy JP, Kovacs C, MacPherson PA, Monteith KM, Mansour S, Thanassoulis G, Abrahamowicz M, Zhu Z, Tsoukas C, Ancuta P, Bernard N, Tremblay CL; investigators of the Canadian HIV and Aging Cohort Study. The Canadian HIV and aging cohort study - determinants of increased risk of cardio-vascular diseases in HIV-infected individuals: rationale and study protocol. BMC Infect Dis. 2017 Sep 11;17(1):611. doi: 10.1186/s12879-017-2692-2.
PubMed 28893184
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Systemic Inflammation in People on Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT07030920
- Acronym / sponsor ID
- RESTART / MP-02-2025-12725
- Keywords
- Fostemsavir, Rukobia, sgp120, Perivascular fat attenuation index (P-FAI), uncalcified plaque volume, Systemic inflammation, Cardiovascular Risk Factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Clinique du Quartier Latin, BC Women's Hospital & Health Centre
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, controlled trial of fostemsavir versus standard of care to curb comorbidity in people with well-controlled HIV. (Phase IIb study)
Background and hypothesis: People living with HIV, even when treated with antiretrovirals, develop early onset comorbidities such as cardiovascular disease, cognitive decline and frailty. In a subset of those, this could be due to residual viral particles driving chronic inflammation. Soluble glycoprotein 120 (sgp120) is detectable in close to a third of people living with HIV with undetectable HIV plasma viral loads. It is associated to increased inflammation and immune dysfunction.
People living with HIV with undetectable viral load but detectable soluble HIV gp120 (sgp120) are exposed to chronic inflammation, sustained immune dysfunction, and increased risk of comorbidity. The investigators hypothesize that the addition of fostemsavir, which has been shown to prevents the binding of sgp120 to the human CD4 receptor, to reduce cytokine burst and antibody-dependant cellular citotoxicity, decreased inflammation and immune dysfunction, leading to improved health.
Study population: People living with HIV on antiretroviral therapy, with undetectable viral load and detectable plasmatic sgp120.
Study intervention: The intervention will be either the addition of fostemsavir (Rukobia 600 mg daily) for 24 months to the patient's current ART regimen, or standard of care, which includes the continuation of the ARV regimen and other medications prescribed by their physicians.
Randomization: This is a randomized, open label study with blind outcome adjudication. Randomization will be done in a 1:1 ratio with allocation in parallel arms, stratified by sex and participant statin use at recruitment, through a computerized algorithm with permuted blocks of randomly varying size, to ensure allocation concealment.
Treatment groups:
Arm 1 (active):
- Once daily oral administration (600 mg extended-release tablet) for 24 months Arm 2 (Standard of care)
- Participants will continue to follow their current ART regimen, as well as other medications prescribed by their treating physician throughout the trial
Study procedures: At baseline, participants will undergo a CCTA, grip strenght, a B-CAM (online cognitive testing) and contribute blood to the study biobank. Participants will be randomized during the baseline visit, and those randomized to fostemsavir will start taking study treatment. Visits will be done at month 1, 6, 12, 18, 24 and 27. The duration of treatment will be 24 months. At month 24, the CCTA, grip strenght and cognition measures will be repeated. Participants will contribute to the biobank at each study visit.
Study outcomes:
Primary Outcome: Change in total uncalcified plaque volume between baseline and month 24, contrasted between fostemsavir and standard of care.
Imaging Secondary Outcome: Perivascular fat attenuation index at month 24, adjusted for baseline values.
Clinical Secondary Outcome: Clinical events - time to major adverse cardiovascular event, B-CAM (cognition testing) and grip strength at month 24 (adjusted for baseline values).
Biomarker Secondary Outcomes: Biomarkers identified in biobanking samples (virology, immunology, inflammation).
Safety Secondary Outcomes: Risk of adverse events and incidence of treatment discontinuation due to side effects.
A biomarker interim analysis will be performed when 50% of the planned samples size will have completed 1 year of follow-up. Pre-specified biomarker outcomes will be measured using the study-associated biobank.
The intervention will be either the addition of fostemsavir (Rukobia 600 mg daily) to the patient's current ART regimen, or the participant receiving the standard of care.
Statistical considerations:
The planned sample size is 150 (approxiimately 75 per arrm. ) Statistical analysis will be conducted by CITADEL (CRCHUM) after the closing of the study database, according to the statistical analysis plan, which will be registered before the analysis is conducted. All analyses will be done by intention-to-treat; patients will be analyzed in the group they were randomized to. Biobank analyses planned after 50% of participants completed the 12 months biobanking will be done by CITADEL after this part of the data collection is closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be done in a 1:1 ratio, with allocation in parallel arms, stratified by sex and participant statin use at recruitment, through a computerized algorithm with permuted blocks of randomly varying size, to ensure allocation concealment.
| Arm | Type | Receives |
|---|---|---|
| Rukobia 600 mg daily | Experimental | Drug: Fostemsavir |
| Standard of care (SOC) | No intervention | –Participants will continue to follow their current ART regimen, as well as other medications prescribed by their treating physician throughout the trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FostemsavirAddition of fostemsavir to the patient's current antiretroviral regimen: once daily oral administration (Rukobia 600 mg extended-release tablets) for 24 months | Drug | Rukobia 600 mg daily |
Primary outcome
Change in total uncalcified plaque volume between baseline and month 24
Time frame: From baseline to end of treatment (+ 24 months)
The change in total uncalcified plaque volume between baseline and month 24 will be measured by coronary compted tomography angiography and contrasted between fostemsavir and standard of care
5 secondary outcomes
Imaging outcome: Perivascular fat attenuation index at month 24, adjusted for baseline values
Time frame: From baseline to end of treatment (+ 24 months)
Time to Major Adverse cardiovascular Event (MACE)
Time frame: From baseline to post-treatment visit (+ 27 months)
Risk of severe and serious adverse events
Time frame: From baseline to post-treatment visit (+ 27 months)
Grip strength at 24 months, adjusted for baseline
Time frame: From baseline to end of treatment (+ 24 months)
Brief Cognitive Ability Measure (B-CAM) scores at month 24, adjusted for baseline
Time frame: From baseline to end of treatment (+ 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 38035854Benlarbi M, Richard J, Bourassa C, Tolbert WD, Chartrand-Lefebvre C, Gendron-Lepage G, Sylla M, El-Far M, Messier-Peet M, Guertin C, Turcotte I, Fromentin R, Verly MM, Prevost J, Clark A, Mothes W, Kaufmann DE, Maldarelli F, Chomont N, Begin P, Tremblay C, Baril JG, Trottier B, Trottier S, Duerr R, Pazgier M, Durand M, Finzi A. Plasma Human Immunodeficiency Virus 1 Soluble Glycoprotein 120 Association With Correlates of Immune Dysfunction and Inflammation in Antiretroviral Therapy-Treated Individuals With Undetectable Viremia. J Infect Dis. 2024 Mar 14;229(3):763-774. doi: 10.1093/infdis/jiad503.
- Background: PubMed 36958337Richard J, Prevost J, Bourassa C, Brassard N, Boutin M, Benlarbi M, Goyette G, Medjahed H, Gendron-Lepage G, Gaudette F, Chen HC, Tolbert WD, Smith AB 3rd, Pazgier M, Dube M, Clark A, Mothes W, Kaufmann DE, Finzi A. Temsavir blocks the immunomodulatory activities of HIV-1 soluble gp120. Cell Chem Biol. 2023 May 18;30(5):540-552.e6. doi: 10.1016/j.chembiol.2023.03.003. Epub 2023 Mar 22.
- Background: PubMed 21499115Durand M, Sheehy O, Baril JG, Lelorier J, Tremblay CL. Association between HIV infection, antiretroviral therapy, and risk of acute myocardial infarction: a cohort and nested case-control study using Quebec's public health insurance database. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):245-53. doi: 10.1097/QAI.0b013e31821d33a5.
- Background: PubMed 28893184Durand M, Chartrand-Lefebvre C, Baril JG, Trottier S, Trottier B, Harris M, Walmsley S, Conway B, Wong A, Routy JP, Kovacs C, MacPherson PA, Monteith KM, Mansour S, Thanassoulis G, Abrahamowicz M, Zhu Z, Tsoukas C, Ancuta P, Bernard N, Tremblay CL; investigators of the Canadian HIV and Aging Cohort Study. The Canadian HIV and aging cohort study - determinants of increased risk of cardio-vascular diseases in HIV-infected individuals: rationale and study protocol. BMC Infect Dis. 2017 Sep 11;17(1):611. doi: 10.1186/s12879-017-2692-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madeleine Durand, STUDY SPONSOR contact
Madeleine Durand, MD MSc FRCPC principal investigator
CR CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fostemsavir in people with Human Immunodeficiency Virus (HIV) and Cardiovascular Risk Factor, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Branka Vulesevic, TRIAL MANAGER (15148908000 ext. 15447, branka.vulesevic.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total uncalcified plaque volume between baseline and month 24 (time frame: From baseline to end of treatment (+ 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07030920, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.