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NCT06856174RecruitingPhase 4

Menopausal HT for Women Living With HIV (HoT)

Menopausal Hormone Therapy for Women Living With HIV (HoT)

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
105 (estimated)
First submitted
19 Feb 2025
Start date
9 Apr 2026
Primary completion date
20 Sept 2027
Lead sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Diseases
HIV
NCT number
NCT06856174

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 105
  • From 9 Apr 2026 to the primary completion date, 20 Sept 2027
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 40 years to 60 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Ponce de Leon Center CRS (5802)
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AtlantaUnited StatesRecruiting
University of Colorado Hospital CRS (6101)
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AuroraUnited StatesRecruiting
201 Johns Hopkins University CRS
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BaltimoreUnited StatesRecruiting
31788 Alabama CRS
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BirminghamUnited StatesRecruiting
Brigham and Women's Hosp. ACTG CRS (107)
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BostonUnited StatesRecruiting
101 Massachusetts General Hospital (MGH) CRS
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BostonUnited StatesRecruiting
3201 Chapel Hill CRS
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Chapel HillUnited StatesRecruiting
Northwestern University CRS (2701)
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ChicagoUnited StatesRecruiting
2401 Cincinnati CRS
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CincinnatiUnited StatesRecruiting
Case CRS (2501)
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ClevelandUnited StatesRecruiting
Ohio State University CRS (2301)
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ColumbusUnited StatesRecruiting
3203 Greensboro CRS
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GreensboroUnited StatesRecruiting
Houston AIDS Research Team CRS (31473)
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HoustonUnited StatesRecruiting
University of California, Los Angeles CARE Center CRS (601)
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Los AngelesUnited StatesRecruiting
New Jersey Medical School Clinical Research Center CRS (31786)
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NewarkUnited StatesRecruiting
Columbia Physicians and Surgeons (P&S) CRS (30329)
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New YorkUnited StatesRecruiting
Weill Cornell Chelsea CRS (7804)
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New YorkUnited StatesRecruiting
6201 Penn Therapeutics CRS
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PhiladelphiaUnited StatesRecruiting
Univ of Pittsburgh
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PittsburghUnited StatesRecruiting
UCSD Antiviral Research Center CRS (701)
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San DiegoUnited StatesRecruiting
801 University of California, San Francisco HIV/AIDS CRS
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San FranciscoUnited StatesRecruiting
2101 Washington University Therapeutics (WT) CRS
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St LouisUnited StatesRecruiting
Harbor - UCLA Med. Ctr. CRS
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TorranceUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.