NCT07284082 · University of California, San Francisco
The Synergistic Effects of Menopause and HIV on Cardiovascular Disease Risk in Women
What this study is about
Menopause is associated with the acceleration of many comorbidities, including cardiovascular disease. Whether HIV and menopause together increase cardiovascular disease risk is a key knowledge gap.
View original scientific description
Menopause is associated with the acceleration of many comorbidities, including cardiovascular disease. Whether HIV and menopause together increase cardiovascular disease risk is a key knowledge gap. The goal of this observational study is to address this knowledge gap by looking at the role of menopause on cardiovascular disease risk factors such as insulin resistance, hypertension, hyperlipidemia, and carotid atherosclerosis using previously collected data. The investigators will look at underlying causes for cardiovascular diseases worsening in menopausal women with HIV by looking at the role of increased inflammation in the body and whether this is altered by weight. The investigators achieve this by enrolling participants who are willing to undergo a whole body MRI.
Interventions
DIAGNOSTIC_TEST
Whole body MRI
Whole body MRI will be performed as part of a study protocol
Primary outcome measures
Markers of immune activation and inflammation
Time frame: These markers will be measured from blood work collected at the scheduled study visit [Day 1] close to the time of MRI and thus will be collected at only one time point.
sCD14 (monocyte activation), sCD163 (M2 macrophage activation), CRP (inflammation), IL-6 (inflammation), IP-10 (interferon-inducible protein), TNFα (inflammation), MCP-1 (inflammation), sTNFRI \& RII (inflammation). There are no units as they will be normalized based upon their interquartile range.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 90 non-pregnant women with HIV (approximately 30 in each menopausal phase) from the San Francisco MWCCS site.
Exclusion criteria
- Women who are not virally suppressed (HIV RNA \>200 copies/mL)
- Women who are not on antiretroviral therapy
- Women who have a history of hysterectomy or oophorectomy
- Women who are receiving treatment for active cancer or tuberculosis
Where
- San Francisco, California
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations