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NCT06856174PHASE4Recruiting

Menopausal HT for Women Living With HIV (HoT)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Start Date

4/9/2026

Completion Date

9/20/2027

Summary

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

Eligibility Criteria

Age Range: 40 years to 60 years

* 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

Interventions

DRUG

Transdermal estradiol gel

DRUG

Micronized Progesterone

DRUG

Placebo for estradiol gel

DRUG

Placebo for micronized progesterone

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Conditions

HIV InfectionMenopause

Locations

31788 Alabama CRS

Birmingham, Alabama 35294

United States

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

Los Angeles, California 90035

United States

UCSD Antiviral Research Center CRS (701)

San Diego, California 92103

United States

801 University of California, San Francisco HIV/AIDS CRS

San Francisco, California 94110

United States

Harbor - UCLA Med. Ctr. CRS

Torrance, California 90502

United States

University of Colorado Hospital CRS (6101)

Aurora, Colorado 80045

United States

The Ponce de Leon Center CRS (5802)

Atlanta, Georgia 30308

United States

Northwestern University CRS (2701)

Chicago, Illinois 60611

United States

201 Johns Hopkins University CRS

Baltimore, Maryland 21205

United States

101 Massachusetts General Hospital (MGH) CRS

Boston, Massachusetts 02114

United States

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

Boston, Massachusetts 02115

United States

2101 Washington University Therapeutics (WT) CRS

St Louis, Missouri 63110

United States

New Jersey Medical School Clinical Research Center CRS (31786)

Newark, New Jersey 07103

United States

Weill Cornell Chelsea CRS (7804)

New York, New York 10010

United States

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

New York, New York 10032

United States

3201 Chapel Hill CRS

Chapel Hill, North Carolina 27516

United States

3203 Greensboro CRS

Greensboro, North Carolina 27401

United States

2401 Cincinnati CRS

Cincinnati, Ohio 45267-0405

United States

Case CRS (2501)

Cleveland, Ohio 44106

United States

Ohio State University CRS (2301)

Columbus, Ohio 43210

United States

6201 Penn Therapeutics CRS

Philadelphia, Pennsylvania 19104

United States

Univ of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States

Houston AIDS Research Team CRS (31473)

Houston, Texas 77030

United States