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

NCT ID: NCT07284082

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2030-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Menopause Cardiovascular (CV) Risk Carotid Arteriosclerosis Body Composition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MACS-WIHS Combined Cohort Study

Whole body MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whole body MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rebecca Abelman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rebecca A Abelman, MD

Role: CONTACT

415-221-4810 ext. 23613

Stacy Polos

Role: CONTACT

415-689-0915

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23HL178394

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-43802

Identifier Type: -

Identifier Source: org_study_id