ACTG A5424: Menopausal Hormone Therapy for Women Living with HIV (HoT)

Treatment Experienced

Menopausal hormone therapy (MHT) is considered the most effective therapy for vasomotor symptoms (VMS; also known as hot flashes and night sweats), and the most appropriate choice to prevent bone loss during menopause. However, the safety and effectiveness of menopausal MHT has not specifically been studied in women living with HIV (WLWH).

 

“HoT” is a trial of MHT (transdermal estradiol with or without oral progesterone) versus placebo for WLWH in the late menopausal transition or early postmenopause with moderate to severe VMS. Study participants will record their VMS in a daily diary for 3 to 5 weeks. Those meeting VMS eligibility criteria will then be randomized to receive either study medication (MHT) or placebo and record their VMS in a daily diary for 12 weeks.

To provide evidence to support guidelines regarding the use of MHT for treating VMS in WLWH.

Who can join?

• Living with HIV
• Assigned female sex at birth, between ages 40 and 60 years
• In the late menopausal transition (perimenopause) or early postmenopause
• Self-report of an average of 2 or more moderate or severe menopausal VMS per day
• Receiving HIV medication for more than 1 year with HIV viral load less than 200 copies
• No use of hormones of any kind, for contraception or menopausal hormone therapy, within 60 days
• Not pregnant and must agree to use at least one form of contraception/birth control if participating in sexual activity that could lead to pregnancy
• Willing and able to complete a daily diary

What do I need to do in the study?

Step 1: (At least 3 weeks and up to 5 weeks) Participants will record VMS in a daily diary; no study treatment is provided.

Step 2: (12 weeks) Eligible participants will be randomized 2:1 to receive either:

• Menopausal hormone therapy (transdermal estradiol gel in single-dose packets plus progesterone* oral capsule) OR
• Placebos (placebo transdermal gel in single-dose packets plus oral placebo capsules).

*Given to those with a uterus.

 

Participants will complete a daily diary of their symptoms as well as questionnaires, blood tests, and clinical, physical function, and neurocognitive assessments during study visits.

Estradiol gel 0.1%, 0.75 grams, plus encapsulated micronized progesterone 100 mg (if uterus intact).

Participants will be in this study for approximately 5 months.