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New treatment option for HIV-1-infection
Official title Improving Coronary Vascular Health in Women
ClinicalTrials.gov ID: NCT06843902
What this study is testing
- What it's testing
- Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed.
- 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 45 to 75, women only
You may be able to join if
- female sex-at-birth
- self-report of HIV on stable antiretroviral therapy ≥180 days
- age 45 -75 years
- at least 1 of the following 3 conditions: i) type 2 diabetes mellitus ii) estimated glomerular filtration rate 30-60 ml/min/1.73 m2 iii) urine...
- coronary flow reserve \<2.5 or stress myocardial blood flow \<2.5 on screening cardiac positron emission tomography/computed tomography
You likely can't join if
- current SGLT2 inhibitor use
- known allergy to SGLT2 inhibitor use
- type 1 diabetes or ketoacidosis prone diabetes (diabetes with a history of ketoacidosis)
- self-reported history of polycystic kidney disease
- self-reported history of myocardial infarction, stroke, or coronary revascularization
- stable or unstable angina
See the full eligibility criteria
- female sex-at-birth
- self-report of HIV on stable antiretroviral therapy ≥180 days
- age 45 -75 years
- at least 1 of the following 3 conditions: i) type 2 diabetes mellitus ii) estimated glomerular filtration rate 30-60 ml/min/1.73 m2 iii) urine albumin to creatinine ratio \>30 mg/g
- coronary flow reserve \<2.5 or stress myocardial blood flow \<2.5 on screening cardiac positron emission tomography/computed tomography
- current SGLT2 inhibitor use
- known allergy to SGLT2 inhibitor use
- type 1 diabetes or ketoacidosis prone diabetes (diabetes with a history of ketoacidosis)
- self-reported history of polycystic kidney disease
- self-reported history of myocardial infarction, stroke, or coronary revascularization
- stable or unstable angina
- self-reported history of heart failure
- hemoglobin A1c ≥8.5% at screen
- uncontrolled hypertension at screen, defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg
- estimated glomerular filtration rate \<30 ml/min/1.73 m2
- currently receiving hemodialysis or peritoneal dialysis
- CD4 \<400 cell/mm3
- current treatment with systemic (oral, IV, IM or intra-articular) steroids or anti-inflammatory/immune suppressant therapies (excluding topical therapies, UV therapy, ASA-derivatives, or NSAIDs) for any indication...
- pregnancy or breastfeeding
- known allergy to 13N Ammonia/82Rubidium or to Regadenoson/Adenosine
- concurrent enrollment in conflicting research study
- self-reported history of recurrent urinary tract-infections (≥2 urinary tract infections within 6 months or ≥3 within a year) and/or recurrent vaginal yeast infections (≥2 vaginal yeast infections within 6 months or ≥3...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
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 female, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. 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.