Menopausal HT for Women Living With HIV (HoT)
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: HIV Infection, Menopause
In brief
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
Key facts
- Study ID
- NCT06856174
- Run by
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- People needed
- 105
- Starts
- 2026-04-09
- Expected to finish
- 2027-09-20
- Last updated by the study team
- 2026-05-22
Who can join
Age: 40 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
Where it is running
- 31788 Alabama CRS — Birmingham, Alabama, United States (enrolling)
- University of California, Los Angeles CARE Center CRS (601) — Los Angeles, California, United States (enrolling)
- UCSD Antiviral Research Center CRS (701) — San Diego, California, United States (enrolling)
- 801 University of California, San Francisco HIV/AIDS CRS — San Francisco, California, United States (enrolling)
- Harbor - UCLA Med. Ctr. CRS — Torrance, California, United States (enrolling)
- University of Colorado Hospital CRS (6101) — Aurora, Colorado, United States (enrolling)
- The Ponce de Leon Center CRS (5802) — Atlanta, Georgia, United States (enrolling)
- Northwestern University CRS (2701) — Chicago, Illinois, United States (enrolling)
- 201 Johns Hopkins University CRS — Baltimore, Maryland, United States (enrolling)
- 101 Massachusetts General Hospital (MGH) CRS — Boston, Massachusetts, United States (enrolling)
- Brigham and Women's Hosp. ACTG CRS (107) — Boston, Massachusetts, United States (enrolling)
- 2101 Washington University Therapeutics (WT) CRS — St Louis, Missouri, United States (enrolling)
- New Jersey Medical School Clinical Research Center CRS (31786) — Newark, New Jersey, United States (enrolling)
- Weill Cornell Chelsea CRS (7804) — New York, New York, United States (enrolling)
- Columbia Physicians and Surgeons (P&S) CRS (30329) — New York, New York, United States (enrolling)
- 3201 Chapel Hill CRS — Chapel Hill, North Carolina, United States (enrolling)
- 3203 Greensboro CRS — Greensboro, North Carolina, United States (enrolling)
- 2401 Cincinnati CRS — Cincinnati, Ohio, United States (enrolling)
- Case CRS (2501) — Cleveland, Ohio, United States (enrolling)
- Ohio State University CRS (2301) — Columbus, Ohio, United States (enrolling)
- 6201 Penn Therapeutics CRS — Philadelphia, Pennsylvania, United States (enrolling)
- Univ of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
- Houston AIDS Research Team CRS (31473) — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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