Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
40 – 60
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
105 (estimated)
Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Research network
Who this trial is looking for
This trial is looking for women aged 40 to 60 living with HIV who experience hot flashes or night sweats. Participants will receive hormone therapy and keep a daily diary to help assess its effects on their symptoms and overall health.
Are You a Good Fit for This Trial?
You may be able to join if
I live with HIV
I was assigned female sex at birth
I am between the ages of 40 and 60
I am experiencing hot flashes and/or night sweats
I have been taking HIV medication for more than 1 year
I am willing to use non-hormonal birth control
I can complete a daily diary
I can provide informed consent after discussion with the research staff
You may not be able to join if
I have a medical condition that would prevent me from taking hormone therapy
I take medications to treat hot flashes
I take medications that can't be combined with hormone therapy
I am currently pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Ho…
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
Trial Locations
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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 c…
* 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
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