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New treatment option for Human Immunodeficiency Virus (HIV)
Official title Reducing Systemic Inflammation in People on Antiretroviral Therapy
ClinicalTrials.gov ID: NCT07030920
What this study is testing
What is Fostemsavir?
Fostemsavir is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for human immunodeficiency virus (hiv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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;
You likely can't join if
- Known allergy to study drug;
- Concomitant treatment with strong cytochrome P450 (CYP3A) inducers, including but not limited to: carbamazepine, phenytoin (anticonvulsants)...
- Planning to become pregnant, pregnant, or breastfeeding (as requested per product monography (55)). Females of childbearing potential must have a...
- Contraindication for CT scan use (estimated glomerular filtration rate [eGFR] less than 40ml/min using the Modification of Diet in Renal Diseases...
- Elevated risk of prior ionizing radiation exposure outside clinical care exceeding 10 mSV over 3 years, per the investigator's judgement (eg. a...
- Confirmed uncorrected QT value \>500ms or confirmed QTcF \>470 msec for women and \>450 msec for men;
See the full eligibility 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...
- 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.
- 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)...
- 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...
- 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...
- 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 (\ 1.5x upper limit of normal [ULN]), known biliary abnormalities (except...
- 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 treatment trial;
- Known Congestive heart failure with NYHA class 3 or 4.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.