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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Whole body MRI
Diagnostic testWhole body MRI will be performed as part of a study protocol
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator