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

April 20, 2026 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California, San Francisco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with HIV who are enrolled in the MWCCS.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MACS-WIHS Combined Cohort Study
Diagnostic test: Whole body MRI
Whole body MRI will be performed as part of a study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Rebecca Abelman, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-43802
  • K23HL178394 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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