Status
Recruiting
Phase
N/A
Study type
Observational
Enrollment
90
Sex
Women only
Ages
Ages 18 Years and up
Primary completion
2030-03-01
Last update
2026-04-22

What this trial studies

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.

Conditions in scope

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

Interventions

  • Whole body MRI (Diagnostic Test) — Whole body MRI will be performed as part of a study protocol

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

  • 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
San Francisco California University of California, San Francisco Recruiting

Status & timeline

  • Overall status: Recruiting
  • Study type: Observational
  • Phase: N/A
  • Start date: 2026-04-17
  • Primary completion: 2030-03-01
  • Last update posted: 2026-04-22
  • First posted: 2025-12-16

Lead sponsor: University of California, San Francisco (Other)

Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • Markers of immune activation and inflammation (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.

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.

Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07284082 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.