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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07284082
Enrollment
90
Registered
2025-12-16
Start date
2025-12-15
Completion date
2030-03-01
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Menopause, Cardiovascular (CV) Risk, Carotid Arteriosclerosis, Body Composition

Brief summary

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_TESTWhole body MRI

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Markers of immune activation and inflammationThese 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.

Countries

United States

Contacts

Primary ContactRebecca A Abelman, MD
rebecca.abelman@ucsf.edu415-221-4810
Backup ContactStacy Polos
stacy.polos@ucsf.edu415-689-0915

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026