Recruiting

NCT Number: NCT07284082

The Synergistic Effects of Menopause and HIV on Cardiovascular Disease Risk in Women

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.

Recruiting

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Key information

Conditions

HIV Body Composition Brain Diseases Cardiovascular (CV) Risk Cardiovascular Diseases Carotid Arteriosclerosis Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Menopause Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Rebecca A Abelman, MD

CONTACT

[email protected]

415-223-4810

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Body MRI

Diagnostic Test

Whole body MRI will be performed as part of a study protocol

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca A Abelman, MD

CONTACT

[email protected]

415-221-4810 ext. 23613

Stacy Polos

CONTACT

[email protected]

415-689-0915

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Dec 16, 2025
Registry last updated: Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed