Menopausal HT for Women Living With HIV (HoT)
Menopausal Hormone Therapy for Women Living With HIV (HoT)
Who can join
Ages 40 to 60 · Women
Full eligibility criteria
* 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
About the study
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
What is being tested
- Transdermal estradiol gel (drug)
- Micronized Progesterone (drug)
- Placebo for estradiol gel (drug)
- Placebo for micronized progesterone (drug)
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Participants: 105 · Started: Apr 9, 2026
Contact the study team
- ACTG ClinicalTrials.gov Coordinator · Phone: 301-628-3348
Official record on ClinicalTrials.gov — NCT06856174
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.