Menopausal HT for Women Living With HIV (HoT) (NCT06856174) | Clinical Trial Compass
RecruitingPhase 4
Menopausal HT for Women Living With HIV (HoT)
United States105 participantsStarted 2026-04-09
Plain-language summary
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
Who can participate
Age range
40 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in vasomotor symptoms (VMS) frequency
Timeframe: From 5 weeks prior to randomization to Week 12
Trial details
NCT IDNCT06856174
SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections