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

NCT07284082 | Recruiting

• 2 other identifiers: 25-43802K23HL178394
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Markers of immune activation and inflammation

  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.

  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.

Study Arms (1)

MACS-WIHS Combined Cohort Study

Diagnostic Test: Whole body MRI

Interventions

Whole body MRI DIAGNOSTIC_TEST

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

MACS-WIHS Combined Cohort Study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with HIV who are enrolled in the MWCCS.

You may qualify if:

• non-pregnant women with HIV (approximately 30 in each menopausal phase) from the San Francisco MWCCS site.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rebecca Abelman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca A Abelman, MD

CONTACT

415-221-4810; rebecca.abelman@ucsf.edu

Stacy Polos

CONTACT

415-689-0915; stacy.polos@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: April 17, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)