Clinical trial NCT06856174: Menopausal HT for Women Living With HIV (HoT)
Official title: Menopausal Hormone Therapy for Women Living With HIV (HoT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: HIV Infection
Menopause
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute on Aging (NIA)
name: Exeltis
name: Xiromed LLC
First posted: 2025-03-04
Enrollment: 105
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in vasomotor symptoms (VMS) frequency
timeFrame: From 5 weeks prior to randomization to Week 12
Secondary outcomes:
measure: Change in vasomotor symptom (VMS) severity
timeFrame: From 5 weeks prior to randomization to week 12
measure: Change in sleep
timeFrame: From randomization to week 12
measure: Change in insomnia
timeFrame: From randomization to week 12
measure: Change in quality of life
timeFrame: From randomization to week 12
measure: Percentage of participants with adverse events associated with hormone therapy
timeFrame: From randomization to week 12
measure: Percentage of participants with occurrence of abnormal vaginal bleeding
timeFrame: From randomization to week 12
measure: Percentage of participants with intolerance of hormone therapy
timeFrame: From randomization to week 12
measure: Change in neurocognitive test results
timeFrame: From randomization to week 12
measure: Change in depression symptoms
timeFrame: From randomization to week 12
measure: Change in anxiety symptoms
timeFrame: From randomization to week 12
measure: Change in weight
timeFrame: From randomization to week 12
measure: Change in body mass index (BMI)
timeFrame: From randomization to week 12
measure: Change in waist circumference
timeFrame: From randomization to week 12
measure: Change in waist-to-hip ratio
timeFrame: From randomization to week 12
measure: Change in sexual function
timeFrame: From randomization to week 12
measure: Percentage of participants with female sexual distress
timeFrame: Week 12 visit
Other outcomes:
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