Menopausal HT for Women Living With HIV (HoT)

Launched by ADVANCING CLINICAL THERAPEUTICS GLOBALLY FOR HIV/AIDS AND OTHER INFECTIONS · Feb 28, 2025

Keywords

ClinConnect Summary

The Menopausal HT for Women Living With HIV (HoT) trial is researching whether hormone therapy can help women living with HIV who are experiencing hot flashes and night sweats. These symptoms can be more severe in women with HIV and can lead to sleep problems, anxiety, and a lower quality of life. The study aims to find out if hormone therapy—using hormones like estradiol alone or with progesterone—can improve not only these hot flashes but also mood, sleep, mental function, bone health, heart health, and inflammation in women living with HIV.

To be eligible for this trial, participants must be assigned female at birth, between the ages of 40 and 60, and currently living with HIV. They should be experiencing hot flashes or night sweats and must not be on medications that treat these symptoms. Potential participants should also be receiving HIV treatment for at least a year and must not be pregnant. They will be asked to keep a daily diary about their symptoms during the study. This trial is not yet recruiting, but it represents an important step in understanding how hormone therapy can help improve the lives of women living with HIV during menopause.

Gender

FEMALE

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