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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Women with HIV who are enrolled in the MWCCS.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Whole body MRI

    Diagnostic test

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

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: MACS-WIHS Combined Cohort Study1 intervention

Trial outcomes

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator