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

Full record on ClinicalTrials.gov

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