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Could hormone therapy cool hot flashes for women with HIV?

NCT ID NCT06856174

Symptom relief Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether hormone therapy (estrogen with or without progesterone) can safely reduce hot flashes and night sweats in women living with HIV. Researchers will also check if it improves sleep, mood, thinking, bone health, and quality of life. About 105 women aged 40 to 60 who are perimenopausal or early postmenopausal and on HIV treatment will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 60 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Living with HIV * Assigned female sex at birth * Between the ages of 40 and 60 years * In the late menopausal transition (perimenopause) or early postmenopause * Experiencing hot flashes and/or night sweats * Willing and able to complete a daily diary * Does not have medical condition that would contraindicate hormone therapy * Not taking medications to treat hot flashes * Not taking medications that cannot be combined with hormone therapy * Receiving antiretrovirals (HIV medication) for more than 1 year * Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy * Willing and able to provide informed consent after discussion with the research staff

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infection Menopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 101 Massachusetts General Hospital (MGH) CRS

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • 201 Johns Hopkins University CRS

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • 2101 Washington University Therapeutics (WT) CRS

    RECRUITING

    St Louis, Missouri, 63110, United States

  • 2401 Cincinnati CRS

    RECRUITING

    Cincinnati, Ohio, 45267-0405, United States

  • 31788 Alabama CRS

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • 3201 Chapel Hill CRS

    RECRUITING

    Chapel Hill, North Carolina, 27516, United States

  • 3203 Greensboro CRS

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • 6201 Penn Therapeutics CRS

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • 801 University of California, San Francisco HIV/AIDS CRS

    RECRUITING

    San Francisco, California, 94110, United States

  • Brigham and Women's Hosp. ACTG CRS (107)

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Case CRS (2501)

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Columbia Physicians and Surgeons (P&S) CRS (30329)

    RECRUITING

    New York, New York, 10032, United States

  • Harbor - UCLA Med. Ctr. CRS

    RECRUITING

    Torrance, California, 90502, United States

  • Houston AIDS Research Team CRS (31473)

    RECRUITING

    Houston, Texas, 77030, United States

  • New Jersey Medical School Clinical Research Center CRS (31786)

    RECRUITING

    Newark, New Jersey, 07103, United States

  • Northwestern University CRS (2701)

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ohio State University CRS (2301)

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Ponce de Leon Center CRS (5802)

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • UCSD Antiviral Research Center CRS (701)

    RECRUITING

    San Diego, California, 92103, United States

  • Univ of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of California, Los Angeles CARE Center CRS (601)

    RECRUITING

    Los Angeles, California, 90035, United States

  • University of Colorado Hospital CRS (6101)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Weill Cornell Chelsea CRS (7804)

    RECRUITING

    New York, New York, 10010, United States

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Other studies related to the condition(s) this trial covers.