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
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ponce de Leon Center CRS (5802) Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Colorado Hospital CRS (6101) Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| 201 Johns Hopkins University CRS Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| 31788 Alabama CRS Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Brigham and Women's Hosp. ACTG CRS (107) Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| 101 Massachusetts General Hospital (MGH) CRS Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| 3201 Chapel Hill CRS Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Northwestern University CRS (2701) Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| 2401 Cincinnati CRS Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Case CRS (2501) Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Ohio State University CRS (2301) Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| 3203 Greensboro CRS Coordinator of this site? Confirm its status | Greensboro | United States | Recruiting |
| Houston AIDS Research Team CRS (31473) Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of California, Los Angeles CARE Center CRS (601) Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| New Jersey Medical School Clinical Research Center CRS (31786) Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Columbia Physicians and Surgeons (P&S) CRS (30329) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Weill Cornell Chelsea CRS (7804) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| 6201 Penn Therapeutics CRS Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Univ of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UCSD Antiviral Research Center CRS (701) Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| 801 University of California, San Francisco HIV/AIDS CRS Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| 2101 Washington University Therapeutics (WT) CRS Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Harbor - UCLA Med. Ctr. CRS Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.