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Clinical trialNCT06856174RecruitingPhase 4Interventional

Menopausal HT for Women Living With HIV (HoT)

SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsEnrollment105HIV InfectionMenopause
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: * There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV * Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV * Hormone therapy is safe and tolerable for women living with HIV

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 31788 Alabama Crs

    Birmingham, Alabama, United States

    Sonya Heath, MD
    Recruiting
  • University of California, Los Angeles Care Center Crs (601)

    Los Angeles, California, United States

    Kara Chew, MD, MS
    Recruiting
  • Ucsd Antiviral Research Center Crs (701)

    San Diego, California, United States

    Timothy Wilkin, MD, MPH
    Recruiting
  • 801 University of California, San Francisco Hiv/aids Crs

    San Francisco, California, United States

    Annie Luetkemeyer, MD
    Recruiting
  • Harbor - Ucla Med. Ctr. Crs

    Torrance, California, United States

    Eric S. Daar, MD
    Recruiting
  • University of Colorado Hospital Crs (6101)

    Aurora, Colorado, United States

    Kristine Erlandson, MD
    Recruiting
  • the Ponce de Leon Center Crs (5802)

    Atlanta, Georgia, United States

    Valeria Cantos, MD
    Recruiting
  • Northwestern University Crs (2701)

    Chicago, Illinois, United States

    Amesika Nyaku, MD, MS
    Recruiting
  • 201 Johns Hopkins University Crs

    Baltimore, Maryland, United States

    Charles Flexner, MD
    Recruiting
  • 101 Massachusetts General Hospital (mgh) Crs

    Boston, Massachusetts, United States

    Rajesh Gandhi, MD
    Recruiting
  • Brigham and Women'S Hosp. Actg Crs (107)

    Boston, Massachusetts, United States

    Jennifer Manne-Goehler, MD
    Recruiting
  • 2101 Washington University Therapeutics (wt) Crs

    St Louis, Missouri, United States

    Rachel Presti, MD, PhD
    Recruiting
  • New Jersey Medical School Clinical Research Center Crs (31786)

    Newark, New Jersey, United States

    Shobha Swaminathan, MD
    Recruiting
  • Columbia Physicians and Surgeons (p&s) Crs (30329)

    New York, New York, United States

    Magdalena Sobieszczyk, MD, MPH
    Recruiting
  • Weill Cornell Chelsea Crs (7804)

    New York, New York, United States

    Kristin Marks, MD
    Recruiting
  • 3201 Chapel Hill Crs

    Chapel Hill, North Carolina, United States

    David A. Wohl, MD
    Recruiting
  • 3203 Greensboro Crs

    Greensboro, North Carolina, United States

    Cornelius Van Dam, MD
    Recruiting
  • 2401 Cincinnati Crs

    Cincinnati, Ohio, United States

    Carl Fichtenbaum, MD
    Recruiting
  • Case Crs (2501)

    Cleveland, Ohio, United States

    George Yendewa, MPH, TM, FACP
    Recruiting
  • Ohio State University Crs (2301)

    Columbus, Ohio, United States

    Carlos Malvestutto, MD, MPH, FIDSA
    Recruiting
  • 6201 Penn Therapeutics Crs

    Philadelphia, Pennsylvania, United States

    Pablo Tebas, MD
    Recruiting
  • Univ of Pittsburgh

    Pittsburgh, Pennsylvania, United States

    Sharon Riddler, MD, MPH
    Recruiting
  • Houston Aids Research Team Crs (31473)

    Houston, Texas, United States

    Roberto Arduino, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Progesterone →Placebo for estradiol gelPlacebo for micronized progesteroneTransdermal estradiol gel
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
9 Apr 2026
Primary completion
20 Sept 2027
Completion
20 Sept 2027
Last update posted
22 May 2026
Registered enrollment
105
Registry id
NCT06856174

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.