Menopausal HT for Women Living With HIV (HoT)

About

Brief 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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 4

Eligibility

Gender

Female

Healthy Volunteers

No

Minimum Age

40 Years

Maximum Age

60 Years

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